- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328688
Clindamycin-trimethoprim/Sulfamethoxazole for PCP After Solid Organ Transplantation Population.
March 28, 2020 updated by: Shanghai Zhongshan Hospital
Clindamycin - Trimethoprim/Sulfamethoxazole for Pneumocystis Jiroveci Pneumonia After Solid Organ Transplantation Population (CTSTOP)
PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated immunodeficiency.With the increasing number of solid organ transplantation, how to effectively treat severe PCP after solid organ transplantation has become an urgent problem to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as second-line alternatives when TMP-SMX fails to treat HIV-PCP.
Therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose TMP-SMX combined with clindamycin (CT regimen) for the treatment of severe PCP after solid organ transplantation.
Study Overview
Status
Completed
Detailed Description
PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated immunodeficiency.With the increasing number of solid organ transplantation, how to effectively treat severe PCP after solid organ transplantation has become an urgent problem to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as second-line alternatives when TMP-SMX fails to treat HIV-PCP.
More and more studies suggest that clindamycin-based alternatives play an increasingly important role in treating of PCP.
Therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose TMP-SMX combined with clindamycin (CT regimen) for the treatment of severe PCP after solid organ transplantation.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200000
- Ju Minjie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A. the clinical manifestations are fever, shortness of breath, dry cough ,respiratory distress B. Chest CT showed manifested by fine, bilateral, perihilar, diffuse infiltrates , an interstitial alveolar butterfly pattern C. Bronchoalveolar lavage was sent for next generation sequencing (NGS)
Description
Inclusion Criteria:
- PJP after solid organ transplantation.
Exclusion Criteria:
- renal failure,heart failure,tumor recurrence
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oxygenation index
Time Frame: through study completion, an average of 20 days
|
PaO2/FiO2
|
through study completion, an average of 20 days
|
length of ICU stay
Time Frame: through study completion, an average of 20 days
|
Total length of stay in ICU
|
through study completion, an average of 20 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse reactions of drugs
Time Frame: through study completion, an average of 20 days
|
Rash,Anorexia,Decreased white blood cell count,Anemia,Decreased platelet count,Increased TB,Increased creatinine,Hyperkalemia
|
through study completion, an average of 20 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
January 2, 2020
First Submitted That Met QC Criteria
March 28, 2020
First Posted (Actual)
March 31, 2020
Study Record Updates
Last Update Posted (Actual)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 28, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTSTOP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pneumocystis Jirovecii Pneumonia
-
Central Hospital, Nancy, FranceCompletedPneumocystis Jirovecii InfectionFrance
-
George Washington UniversityWithdrawnPneumocystis Carinii PneumoniaUnited States
-
National Taiwan University HospitalUnknownPneumocystis Jirovecii PneumoniaTaiwan
-
University Hospital, Strasbourg, FranceRecruitingPneumocystis Jirovecii InfectionFrance
-
Chinese PLA General HospitalActive, not recruitingPneumocystis Jirovecii PneumoniaChina
-
McGill University Health Centre/Research Institute...Not yet recruitingPneumocystis Infections | Pneumocystis Jirovecii Infection | Pneumocystis | Pneumocystis Pneumonia | Pneumocystis Carinii Infection | Pneumocystosis; Pneumonia (Etiology) | Pneumocystis Carinii; Infection, Resulting From HIV Disease | Pneumocystosis Associated With AIDSCanada
-
University of Colorado, DenverUniversity of California, Davis; University of GeorgiaRecruitingCandidiasis | Aspergillosis | Cryptococcosis | Pneumocystis Jirovecii Infection | PneumocystisUnited States
-
University of Illinois at ChicagoCompleted
-
University Hospital, MontpellierCompletedInvasive Fungal Infections | Pulmonary Nodule | Pneumocystis JiroveciiFrance
-
Immtech Pharmaceuticals, IncTerminatedHIV Infections | Pneumonia, Pneumocystis Carinii | Pneumocystis Carinii Pneumonia | Pneumonia, Interstitial Plasma CellUnited States