Safety and Efficacy of Ventricular Irrigation for Ventriculitis

Safety and Efficacy of Ventricular Irrigation for Ventriculitis: a Randomized Controlled Trial

Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.

Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.

This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.

Study Overview

• Status: Recruiting
• Conditions: Central Nervous System Infections
• Intervention / Treatment: Procedure: Ventricular irrigation

Detailed Description

Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Ventriculitis is associated not only with community-acquired diseases but also, more importantly, with invasive clinical procedures, including craniotomy, external ventricular drainage (EVD), lumbar cistern drainage, V-P shunt, and deep brain stimulation, among others. Depending on the diagnostic criteria, the incidence of post-neurosurgery ventriculitis ranges from approximately 5% to 20%, with risk factors including age, prolonged placement of EVD, and intracranial hemorrhage. Besides, the pathogens leading to ventricular infection are also diverse, with the main pathogens including coagulase-negative Staphylococci, Staphylococcus aureus, Propionibacterium acnes, and Gram-negative bacilli.

The treatment for ventriculitis is challenging, with poor prognosis. Under currently widely adopted treatment strategies, the mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy. This imposes significant burden on families and society. Therefore, how to further improve prognosis of ventriculitis, and reduce the mortality and disability rates, remains to be addressed.

Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. As an infectious disease, surgical procedures such as irrigation and drainage have the potential to play a role in reducing infection and improving prognosis for ventriculitis.

In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques (including endoscopic ventricular irrigation and dual catheter irrigation techniques) via replacing saline and draining purulent cerebrospinal fluid (CSF), may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. A prospective controlled study that included 33 patients with ventriculitis divided participants into groups receiving ventricular irrigation treatment and conventional treatment. The study results showed that compared to conventional treatment, ventricular irrigation resulted in higher mRS prognosis scores, shorter hospital stays, and the study also showed a trend towards reduced mortality in irrigation group. However, this study was limited by a small sample size, limited study endpoints and not strictly randomized. Currently, high-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.

Based on these considerations, this multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiyao Jiang, Dr; Phone Number: 021-68383729; Email: jiyaojiang@126.com
• Study Contact Backup: Name: Junfeng Feng, Dr; Phone Number: 13611860825; Email: fengjfmail@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of University of Science and Technology of China
      • Contact: Xiangpin Wei, Dr
    • Hefei, Anhui, China
      • Not yet recruiting
      • The Second People's Hospital of Anhui Province
      • Contact: Yongming Zhang, Dr
    • Wuhu, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of Wannan Medical College
      • Contact: Xuefei Shao, Dr
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Not yet recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Rongcai Jiang, Dr
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Wenhua Fang, Dr
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Qinghua Wang, Dr
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Binghui Qiu, Dr
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Shenzhen Second People's Hospital
      • Contact: Xianjian Huang, Dr
    • Zhongshan, Guangdong, China
      • Not yet recruiting
      • Zhongshan Hospital of Traditional Chinese Medicine
      • Contact: Dan Jin, Dr
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • The First Affiliated Hospital of Harbin Medical University
      • Contact: Hongsheng Liang, Dr
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial People's Hospital
      • Contact: Guang Feng, Dr
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Kai Shu, Dr
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • Xiangya Hospital of Central South University
      • Contact: Jinfang Liu, Dr
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Jiangsu Province Hospital
      • Contact: Jing Ji, Dr
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Chunhua Hang, Dr
    • Nantong, Jiangsu, China
      • Not yet recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Jinlong Shi, Dr
    • Suzhou, Jiangsu, China
      • Not yet recruiting
      • the First Affiliated Hospital of Soochow University
      • Contact: Xiaoou Sun, Dr
    • Wuxi, Jiangsu, China
      • Not yet recruiting
      • 904 Hospital of the People's Liberation Army Joint Logistic Support Force
      • Contact: Yuhai Wang, Dr
    • Yangzhou, Jiangsu, China
      • Not yet recruiting
      • Affiliated Hospital of Yangzhou University
      • Contact: Aijun Peng, Dr
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Not yet recruiting
      • Ganzhou People's Hospital
      • Contact: Qiuhua Jiang, Dr
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Yan Zhang, Dr
  • Liaoning
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • The fourth Affiliated Hospital of China Medical University
      • Contact: Yijun Bao, Dr
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Air Force Medical University
      • Contact: Yan Qu, Dr
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shandong University
      • Contact: Qibing Huang, Dr
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Shanghai Tenth People's Hospital
      • Contact: Xianzhen Chen, Dr
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University
      • Contact: Jiyao Jiang, Dr; Phone Number: 021-68383729; Email: jiyaojiang@126.com
      • Contact: Junfeng Feng, Dr; Phone Number: 13611860825; Email: fengjfmail@163.com
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai Donglei Brain Hospital
      • Contact: Liang Gao, Dr
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Shanghai East Hospital
      • Contact: Chunlong Zhong, Dr
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Naval Medical University
      • Contact: Lijun Hou, Dr
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital, Sichuan University
      • Contact: Chaohua Yang, Dr
  • The Nei Monggol Autonomous Region
    • Hohhot, The Nei Monggol Autonomous Region, China
      • Not yet recruiting
      • Inner Mongolia People's Hospital
      • Contact: Weiping Zhao, Dr
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Yongxin Wang, Dr
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • First Affiliated Hospital of Zhejiang University
      • Contact: Xiaofeng Yang, Dr
    • Huzhou, Zhejiang, China
      • Recruiting
      • South taihu hospital affiliated to huzhou college
      • Contact: Liansheng Long, Dr
    • Ningbo, Zhejiang, China
      • Not yet recruiting
      • The Affiliated People's Hospital of Ningbo University
      • Contact: Feng Gao, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years old;
• CSF is purulent (it appears cloudy or yellow) and white blood cell count over 1000×10^6/L.
• Fever (>38.0°C)
• Meet at least one of the following: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiologic testing method; 2. Cranial CT or MRI indicating intraventricular floccule or pus.
• With consent form

Exclusion Criteria:

• With GCS score of 3
• With unstable vital signs such as no spontaneous breathing and blood pressure maintenance drugs
• With severe propensity for bleeding (Such as coagulation dysfunction, active bleeding, etc.), and unable to tolerate the surgical procedures or operations related to ventricular irrigation treatment.
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventricular irrigation group; Intervention group employs catheter ventricular irrigation with various forms. Lavage is performed with each time at least 200ml of normal saline, and irrigation treatment over 7 days. Additional treatments, including the administration of antibiotics, are consistent with those in the control group.	Procedure: Ventricular irrigation; Catheter ventricular irrigation can be employed by various forms. Lavage is performed with with each time at least 200ml of saline. Aside from lavage sessions, the lavage is paused, but continuous CSF drainage remains open.
No Intervention: Control group; Conventional treatments for ventriculitis, including: external ventricular drainage or lumbar cistern drainage for continuous drainage, systemic and intrathecal antibiotics along with other supportive care. The treatment plan, including the type, dosage, and duration of antibiotics, follows guidelines "2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis" and "Chinese Expert Consensus on Diagnosis and Treatment of Central Nervous System Infections in Neurosurgery (2021 Edition)".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Clinical cure rate at 4 weeks after enrollment and randomization	4 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSF test results	Results of CSF test at 8th day after enrollment, and within 1 week before discharge, including CSF glucose, CSF protein, CSF WBC count and organism(s) identification by a culture or non-culture based microbiologic testing method	At 8th day after enrollment, and within 1 week before discharge
Cranial CT or MRI indicating	Cranial CT or MRI indicating at 8th day after enrollment, and within 1 week before discharge	At 8th day after enrollment, and within 1 week before discharge
GOSE	Extended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis	up 6 months after enrollment and randomization
Length of ICU stay and hospital stay	Length of ICU stay and hospital stay	up to 6 months after enrollment and randomization
Complications	Blood from puncture canal and intracranial during hospitalization	up to 6 months after enrollment and randomization
Microbial clearance rate	Microbial clearance rate at 4 weeks after enrollment and randomization	4 weeks after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Number of participants with complications within 6 months after diagnosis of ventriculitis	Within 6 months after diagnosis

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Xiangya Hospital of Central South University; West China Hospital; Tongji Hospital; Qilu Hospital of Shandong University; First Affiliated Hospital of Fujian Medical University; Shanghai 10th People's Hospital; Xuanwu Hospital, Beijing; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; First Affiliated Hospital of Zhejiang University; The First Affiliated Hospital of Soochow University; The Second Affiliated Hospital of Air Force Medical University; Henan Provincial People's Hospital; Shanghai East Hospital; Shenzhen Second People's Hospital; Yangzhou University; First Affiliated Hospital of Xinjiang Medical University; Southern Medical University, China; Second Affiliated Hospital of Nanchang University; The First Affiliated Hospital of University of Science and Technology of China; First Affiliated Hospital of Harbin Medical University; Inner Mongolia People's Hospital; The Affiliated People's Hospital of Ningbo University; Affiliated Hospital of Nantong University; The Fourth Affiliated Hospital of China Medical University; Zhongshan Hospital Of Traditional Chinese Medicine; Ganzhou People's Hospital; The Second People's Hospital of Anhui Province; Nanfang Hospital, Southern Medical University; Shanghai Donglei Brain Hospital; 904th Hospital of the Joint Logistics Support Force of the PLA; South Taihu Hospital Affiliated to Huzhou College; The First Affiliated Hospital of Wannan Medical College（Yijishan Hospital of Wannan Medical College）; The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)
• Investigators: Principal Investigator: Jiyao Jiang, Dr, Renji Hospital, School of Medicine, Shanghai Jiaotong University; Study Director: Junfeng Feng, Dr, Renji Hospital, School of Medicine, Shanghai Jiaotong University; Study Director: Qinghua Wang, Dr, Southern Medical University, China; Study Director: Xiaofeng Yang, Dr, First Affiliated Hospital of Zhejiang University; Study Director: Xianjian Huang, Dr, Shenzhen Second People's Hospital; Study Director: Xuefei Shao, Dr, First Affiliated Hospital of Wannan Medical College; Study Director: Yuhai Wang, Dr, 904th Hospital of the Joint Logistics Support Force of the PLA; Study Director: Lijun Hou, Dr, The Second Affiliated Hospital of Naval Medical University; Study Director: Chunlong Zhong, Dr, Shanghai East Hospital; Study Director: Liang Gao, Dr, Shanghai Donglei Brain Hospital; Study Director: Rongcai Jiang, Dr, Xuanwu Hospital, Beijing; Study Director: Liansheng Long, Dr, South taihu hospital affiliated to huzhou college; Study Director: Feng Gao, Dr, he affiliated people's hospital of ningbo university; Study Director: Chunhua Hang, Dr, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Study Director: Jing Ji, Dr, The First Affiliated Hospital with Nanjing Medical University; Study Director: Xiaoou Sun, Dr, the First Affiliated Hospital of Soochow University; Study Director: Aijun Peng, Dr, Yangzhou University; Study Director: Jinlong Shi, Dr, Affiliated Hospital of Nantong University; Study Director: Binghui Qiu, Dr, Nanfang Hospital, Southern Medical University; Study Director: Dan Jin, Dr, Zhongshan Hospital of Traditional Chinese Medicine; Study Director: Yongxin Wang, Dr, First Affiliated Hospital of Xinjiang Medical University; Study Director: Chaohua Yang, Dr, West China Hospital; Study Director: Qibing Huang, Dr, Qilu Hospital of Shandong University; Study Director: Yan Qu, Dr, The Second Affiliated Hospital of Air Force Medical University; Study Director: Yan Zhang, Dr, Second Affiliated Hospital of Nanchang University; Study Director: Qiuhua Jiang, Dr, Ganzhou People's Hospital; Study Director: Yijun Bao, Dr, The fourth Affiliated Hospital of China Medical University; Study Director: Hongsheng Liang, Dr, First Affiliated Hospital of Harbin Medical University; Study Director: Wenhua Fang, Dr, First Affiliated Hospital of Fujian Medical University; Study Director: Guang Feng, Dr, Henan Provincial People's Hospital; Study Director: Kai Shu, Dr, Tongji Hospital; Study Director: Jinfang Liu, Dr, Xiangya Hospital of Central South University; Study Director: Weiping Zhao, Dr, Inner Mongolia People's Hospital; Study Director: Yongming Zhang, Dr, The Second People's Hospital of Anhui Province; Study Director: Xiangpin Wei, Dr, The First Affiliated Hospital of University of Science and Technology of China; Study Director: Xianzhen Chen, Dr, Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• Tunkel AR, Hasbun R, Bhimraj A, Byers K, Kaplan SL, Scheld WM, van de Beek D, Bleck TP, Garton HJL, Zunt JR. 2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis. Clin Infect Dis. 2017 Mar 15;64(6):e34-e65. doi: 10.1093/cid/ciw861.
• Hasbun R. Healthcare-associated ventriculitis: current and emerging diagnostic and treatment strategies. Expert Rev Anti Infect Ther. 2021 Aug;19(8):993-999. doi: 10.1080/14787210.2021.1866544. Epub 2020 Dec 24.
• Humphreys H, Jenks PJ. Surveillance and management of ventriculitis following neurosurgery. J Hosp Infect. 2015 Apr;89(4):281-6. doi: 10.1016/j.jhin.2014.12.019. Epub 2015 Jan 29.
• Rogers T, Sok K, Erickson T, Aguilera E, Wootton SH, Murray KO, Hasbun R. Impact of Antibiotic Therapy in the Microbiological Yield of Healthcare-Associated Ventriculitis and Meningitis. Open Forum Infect Dis. 2019 Feb 6;6(3):ofz050. doi: 10.1093/ofid/ofz050. eCollection 2019 Mar.
• Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.
• Karvouniaris M, Brotis AG, Tsiamalou P, Fountas KN. The Role of Intraventricular Antibiotics in the Treatment of Nosocomial Ventriculitis/Meningitis from Gram-Negative Pathogens: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Dec;120:e637-e650. doi: 10.1016/j.wneu.2018.08.138. Epub 2018 Aug 29.
• Luque-Paz D, Revest M, Eugene F, Boukthir S, Dejoies L, Tattevin P, Le Reste PJ. Ventriculitis: A Severe Complication of Central Nervous System Infections. Open Forum Infect Dis. 2021 Apr 29;8(6):ofab216. doi: 10.1093/ofid/ofab216. eCollection 2021 Jun.
• Chan AK, Birk HS, Yue JK, Winkler EA, McDermott MW. Bilateral External Ventricular Drain Placement and Intraventricular Irrigation Combined with Concomitant Serial Prone Patient Positioning: A Novel Treatment for Gravity-Dependent Layering in Bacterial Ventriculitis. Cureus. 2017 Apr 18;9(4):e1175. doi: 10.7759/cureus.1175.
• Terada Y, Mineharu Y, Arakawa Y, Funaki T, Tanji M, Miyamoto S. Effectiveness of neuroendoscopic ventricular irrigation for ventriculitis. Clin Neurol Neurosurg. 2016 Jul;146:147-51. doi: 10.1016/j.clineuro.2016.05.010. Epub 2016 May 9.
• Gaderer C, Schaumann A, Schulz M, Thomale UW. Neuroendoscopic lavage for the treatment of CSF infection with hydrocephalus in children. Childs Nerv Syst. 2018 Oct;34(10):1893-1903. doi: 10.1007/s00381-018-3894-7. Epub 2018 Jul 11.
• Qin G, Liang Y, Xu K, Xu P, Ye J, Tang X, Lan S. Neuroendoscopic lavage for ventriculitis: Case report and literature review. Neurochirurgie. 2020 Apr;66(2):127-132. doi: 10.1016/j.neuchi.2019.12.005. Epub 2020 Feb 19.
• Stati G, Migliorino E, Moneti M, Castioni CA, Scibilia A, Palandri G, Virgili G, Aspide R. Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. J Anesth Analg Crit Care. 2023 Nov 8;3(1):46. doi: 10.1186/s44158-023-00131-5.
• de Sousa Carvalho Dezena JE, Gerbelli CLB, Braga TKK, Ballestero MFM. How I do it: brainwashing for purulent ventriculitis. Acta Neurochir (Wien). 2023 Nov;165(11):3267-3269. doi: 10.1007/s00701-023-05607-5. Epub 2023 May 20.
• Tomita Y, Shimazu Y, Kawakami M, Matsumoto H, Fujii K, Kameda M, Yasuhara T, Suruga Y, Ota T, Kimata Y, Kurozumi K, Date I. Pyogenic Ventriculitis After Anterior Skull Base Surgery Treated With Endoscopic Ventricular Irrigation And Reconstruction Using a Vascularized Flap. Acta Med Okayama. 2021 Apr;75(2):243-248. doi: 10.18926/AMO/61908.
• Ochoa A, Arganaraz R, Mantese B. Neuroendoscopic lavage for the treatment of pyogenic ventriculitis in children: personal series and review of the literature. Childs Nerv Syst. 2022 Mar;38(3):597-604. doi: 10.1007/s00381-021-05413-3. Epub 2021 Nov 13.
• Al Menabbawy A, El Refaee E, Soliman MAR, Elborady MA, Katri MA, Fleck S, Schroeder HWS, Zohdi A. Outcome improvement in cerebral ventriculitis after ventricular irrigation: a prospective controlled study. J Neurosurg Pediatr. 2020 Sep 4;26(6):682-690. doi: 10.3171/2020.5.PEDS2063. Print 2020 Dec 1.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: April 6, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ventriculitis; Ventricular irrigation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections
• Other Study ID Numbers: LY2024-045-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary. A Data Access Agreement is required, and all access must comply with regulatory restrictions imposed on the original study.
• IPD Sharing Time Frame: After Publication
• IPD Sharing Access Criteria: Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No