- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03012529
Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)
CSP #2001 - Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA Intrepid)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled, investigation of a six week course of adjunctive rifampin vs. adjunctive matched placebo (riboflavin) added to backbone antibacterial therapy for the treatment of diabetic foot osteomyelitis. Backbone antibacterial therapy will be with single or multiple agents selected by the clinical treatment team based either on culture results or standard empiric therapy, and which can be administered either intravenously or orally. Rifampin will be dosed at 600 mg daily. The primary outcome measure is amputation-free survival. Amputation events include both below- and above-ankle amputations. Primary outcomes will be determined by systematic medical record review and through confirmatory research visits, phone calls and, as needed, information from non-VA providers. The results for amputation-free survival will be analyzed by means of a two-sided log-rank test. The secondary outcomes of complete wound epithelialization and remission of osteomyelitis will be determined by the research team through VA record review and/or direct examination.
The study will initially enroll and randomize a total of 880 study participants to receive either rifampin or placebo (riboflavin) in addition to backbone antibiotic therapy prescribed by their clinician. Investigators expect to enroll, on average, close to one subject per month per site (10-12 per year/site) at 28 VA medical centers to achieve total randomization of 880 subjects over seven years. In meeting this average site enrollment projection, Investigators anticipate variation in enrollment between larger and smaller sites, and between high-performing and low-performing sites. Subjects will be followed through the end of the second year after randomization or until a study primary endpoint event (amputation or death) occurs. On average, study participants will be followed for 1.8 years through systematic review of medical records, and by study visits and phone calls.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Paul A Monach, MD PhD
- Phone Number: (857) 364-6662
- Email: Paul.Monach@va.gov
Study Contact Backup
- Name: Kayla R Morrison
- Phone Number: (617) 435-6375
- Email: Kayla.Morrison@va.gov
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85012
- Terminated
- Phoenix VA Health Care System, Phoenix, AZ
-
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California
-
Loma Linda, California, United States, 92357-1000
- Active, not recruiting
- VA Loma Linda Healthcare System, Loma Linda, CA
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Long Beach, California, United States, 90822
- Recruiting
- VA Long Beach Healthcare System, Long Beach, CA
-
Contact:
- Christine Ma, MPH
- Email: christine.ma@va.gov
-
Contact:
- Anthony Chau, MD
- Phone Number: 1-8810 562-826-8000
- Email: Anthony.Chau@va.gov
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Palo Alto, California, United States, 94304-1207
- Active, not recruiting
- VA Palo Alto Health Care System, Palo Alto, CA
-
Sacramento, California, United States, 95655
- Recruiting
- VA Northern California Health Care System, Mather, CA
-
Contact:
- Hien Nguyen, MD
- Phone Number: 916-843-9242
- Email: hien.nguyen6@va.gov
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Contact:
- Lam Nguyen, BA
- Email: Lam.Nguyen3@va.gov
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West Los Angeles, California, United States, 90073
- Terminated
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contact:
- Lindsay Nicholson, MD
- Phone Number: 720-723-6772
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Contact:
- Anna Wyrwa, BSN
- Phone Number: (720) 857-5117
- Email: Anna.Wyrwa@va.gov
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Study Chair:
- Mary T Bessesen, MD
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Recruiting
- Washington DC VA Medical Center, Washington, DC
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Contact:
- Angelike Liappis, MD
- Phone Number: 58301 202-745-8000
- Email: angelike.liappis@va.gov
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Contact:
- Shirley Cummins, CCRC
- Email: shirley.cummins@va.gov
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Florida
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Bay Pines, Florida, United States, 33744-0000
- Recruiting
- Bay Pines VA Healthcare System, Pay Pines, FL
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Contact:
- Melissa Abercrombie, DPM
- Phone Number: 17379 727-398-6661
- Email: Melissa.Abercrombie@va.gov
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Contact:
- Cortny Withee, BS
- Email: Cortny.Withee@va.gov
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Gainesville, Florida, United States, 32608-1135
- Active, not recruiting
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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Miami, Florida, United States, 33125
- Terminated
- Miami VA Healthcare System, Miami, FL
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Tampa, Florida, United States, 33612
- Recruiting
- James A. Haley Veterans' Hospital, Tampa, FL
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Contact:
- John Toney, MD
- Phone Number: 6697 813-972-2000
- Email: John.Toney@va.gov
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Contact:
- Natalie Veling, BSN
- Email: Natalie.Veling@va.gov
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Georgia
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Decatur, Georgia, United States, 30033
- Terminated
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Michigan
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Ann Arbor, Michigan, United States, 48105-2303
- Recruiting
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Contact:
- Kathleen Linder, MD
- Phone Number: 734-222-7598
- Email: Kathleen.Linder2@va.gov
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Contact:
- Kimberly Nofz, BSN
- Email: Kimberly.Nofz@va.gov
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Recruiting
- Minneapolis VA Health Care System, Minneapolis, MN
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Contact:
- Derrick Green, MD
- Phone Number: 612-467-7275
- Email: derrick.green@va.gov
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Contact:
- Aigerim Toleuova, MN
- Email: aigerim.toleuova@va.gov
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Missouri
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Saint Louis, Missouri, United States, 63106
- Terminated
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO
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New York
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Bronx, New York, United States, 10468-3904
- Recruiting
- James J. Peters VA Medical Center, Bronx, NY
-
Contact:
- Norbert Brau, MD
- Phone Number: 6672 718-584-9000
- Email: Norbert.Brau@va.gov
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Contact:
- Olga Andriunas, BSN
- Email: Olga.Andriunas@va.gov
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North Carolina
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Salisbury, North Carolina, United States, 28144
- Recruiting
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
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Contact:
- Luis Barroso, MD
- Phone Number: 13570 704-638-9000
- Email: Luis.Barroso@va.gov
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Contact:
- Ashly Hinson, LPN
- Email: Ashly.Hinson@va.gov
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Ohio
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Cincinnati, Ohio, United States, 45220
- Recruiting
- Cincinnati VA Medical Center, Cincinnati, OH
-
Contact:
- George Smulian, MD
- Phone Number: 513-348-6804
- Email: george.smulian@va.gov
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Contact:
- Laura Lach, BS
- Email: Laura.Lach@va.gov
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Cleveland, Ohio, United States, 44106-1702
- Recruiting
- Louis Stokes VA Medical Center, Cleveland, OH
-
Contact:
- Usha Stiefel, MD
- Phone Number: 64788 216-791-3800
- Email: Usha.Stiefel@va.gov
-
Contact:
- Emily Buss, BS
- Email: Emily.Buss1@va.gov
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Dayton, Ohio, United States, 45428
- Recruiting
- Dayton VA Medical Center, Dayton, OH
-
Contact:
- Hari Polenakovik, MD
- Phone Number: 2630 937-268-6511
- Email: hari.polenakovik@va.gov
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Contact:
- Barbara Lane, MSN
- Email: Barbara.Lane@va.gov
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- Oklahoma City VA Medical Center, Oklahoma City, OK
-
Contact:
- George Kurdgelashvili, MD
- Phone Number: 405-456-2544
- Email: George.Kurdgelashvili@va.gov
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Contact:
- Seerat Moutassam, MPH
- Email: Seerat.Moutassam@va.gov
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Oregon
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Portland, Oregon, United States, 97207-2964
- Recruiting
- VA Portland Health Care System, Portland, OR
-
Contact:
- Marissa Maier, MD
- Phone Number: 52363 503-220-8262
- Email: Marissa.Maier@va.gov
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Contact:
- Erik Mauk, BS
- Email: Erik.Mauk@va.gov
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Tennessee
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Nashville, Tennessee, United States, 37212-2637
- Recruiting
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
-
Contact:
- Todd Hulgan, MD
- Phone Number: 615-835-5082
- Email: Todd.Hulgan@va.gov
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Contact:
- Rachel Turgeon, MS
- Email: Rachel.Turgeon@va.gov
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Texas
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Dallas, Texas, United States, 75216
- Recruiting
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
-
Contact:
- David Truong, DPM
- Phone Number: 214-857-0039
- Email: David.Truong1@va.gov
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Contact:
- Sarah Balogun, BS
- Email: Sarah.Balogun@va.gov
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Houston, Texas, United States, 77030
- Recruiting
- Michael E. DeBakey VA Medical Center, Houston, TX
-
Contact:
- Neal Barshes, MD
- Phone Number: 25188 713-791-1414
- Email: neal.barshes@va.gov
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Contact:
- Alexander Uribe-Gomez, MD
- Email: Alexander.Uribe-Gomez@va.gov
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San Antonio, Texas, United States, 78229
- Recruiting
- South Texas Health Care System, San Antonio, TX
-
Contact:
- Jose Cadena Zuluaga, MD
- Phone Number: 14793 210-617-5300
- Email: jose.cadena-zuluaga@va.gov
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Contact:
- Michele Paprocki, MSN
- Email: Michele.Paprocki@va.gov
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Utah
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Salt Lake City, Utah, United States, 84148-0001
- Active, not recruiting
- VA Salt Lake City Health Care System, Salt Lake City, UT
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-
Virginia
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Salem, Virginia, United States, 24153-6404
- Recruiting
- Salem VA Medical Center, Salem, VA
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Contact:
- Shikha Vasudeva, MD
- Phone Number: 3843 540-982-2463
- Email: shikha.vasudeva@va.gov
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Contact:
- Brooke Fuhrey, BS
- Email: Brooke.Fuhrey@va.gov
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Wisconsin
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Madison, Wisconsin, United States, 53705
- Recruiting
- William S. Middleton Memorial Veterans Hospital, Madison, WI
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Contact:
- Christopher Crnich, MD
- Phone Number: 608-843-0438
- Email: christopher.crnich@va.gov
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Contact:
- Kenneth Wagman, BSN
- Email: Kenneth.Wagman@va.gov
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 and 89 years
- Diagnosis of diabetes mellitus, either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; 2) a hemoglobin A1c (HgA1c) level within the past 90 days > 6.5; or 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years
- Definite or probable osteomyelitis in the diabetic foot, as defined by the International Working Group on the Diabetic Foot (Table 1). Criteria must be present at some point within 90 days prior to enrollment.
- All planned debridement has been completed prior to randomization.
- A course of backbone antimicrobial therapy has been selected.
Exclusion Criteria:
- Patient unable to receive enteral medication.
- Patient is allergic to or intolerant of rifampin.
- Patient is taking a drug that has interactions with rifampin that would require either stoppage, substitution or an empiric dose modification that may place the patient at medical risk.
- Within 30 days of enrollment, patient is taking immunosuppressive medications to prevent rejection of an organ transplant or is receiving chemotherapy for cancer or molecularly targeted therapies for cancer.
- Patient is receiving antiretroviral therapy for HIV or antiviral medication for Hepatitis C.
- Patient is participating in another interventional clinical trial for which a waiver of dual enrollment with CSP#2001 has not been obtained.
- Patient has an ALT > 3 times the upper limit of normal for the site laboratory, or total bilirubin > 2.5 times the upper limit of normal for the site laboratory*,***; INR > 1.5, OR patient has Child-Pugh Class C Cirrhosis.
- Patient has a baseline white blood cell count (WBC) <2000 cells/mm3*** OR absolute neutrophil count (ANC) <1000 cells/mm3*** OR platelet count <50,000 cells/mm3**,*** OR hemoglobin <8.0 g/dL.**,***.
- Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test.
- Patient is believed unlikely to be able to complete the trial due to medical conditions.
- Patient is believed unlikely to complete the trial due to neurologic and psycho-behavioral disorders such as active substance abuse or dependence, disabling dementias or psychoses.
- Patient refuses or is clinically unable to undergo the recommended level of debridement.
- Indwelling hardware present in the foot, at the site of the index osteomyelitis.
- Treatment with antibacterial agents for infection at another site, where the duration of treatment is anticipated to be greater than 14 days.
Patient is receiving therapy for COVID-19 that interacts with rifampin.
Patients with total bilirubin > 2 times the ULN who have Gilbert's Disease or any other inherited disease affecting bilirubin metabolism without meeting other exclusionary criteria, may be considered for inclusion in the study.
Patients with platelet count <50,000 cells/mm3 due only to hypersplenism and meeting no other exclusionary criteria may be considered for inclusion in the study.
- If multiple laboratory values are available, the most recent value will be applied for eligibility.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active drug
Patients receive oral adjunctive rifampin therapy
|
Subjects who are randomly assigned to adjunctive rifampin will receive a 600 mg oral daily dose targeted for a six-week period.
If a subject experiences gastrointestinal intolerance on once daily dosing, the study drug may be administered as rifampin 300 mg twice a day.
|
Placebo Comparator: Placebo
Patients receive oral riboflavin
|
A placebo capsule will be administered daily to match frequency and duration of rifampin interventional drug.
For the purpose of mimicking urine discoloration when taking rifampin, riboflavin will be added to the placebo to produce a urine discoloration effect.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amputation-Free Survival
Time Frame: Assessed 2 years post intervention
|
The primary endpoint is amputation-free survival, ending with amputation or death from any cause.
Amputation is defined as surgical treatment of osteomyelitis by removal or debridement of necrotic/infected bone (all or part of a bone) from a lower extremity limb or digit on the ipsilateral side of the protocol-treated osteomyelitis.
Debridement prior to randomization may include removal of bone.
Because this debridement occurs early, prior to exposure to study drug or placebo, removal of bone at that time is not a study endpoint.
|
Assessed 2 years post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Amputation
Time Frame: Assessed 2 years post intervention
|
Time from randomization to the occurrence of the components of the primary outcome:
Endpoint will be determined by chart review by the Study Coordinator, with confirmation by the Site Investigator, and as needed, by the Study Chair. |
Assessed 2 years post intervention
|
New course of antibacterial therapy for ipsilateral foot infection
Time Frame: Assessed 2 years post intervention
|
New courses of antibacterial therapy for ipsilateral foot infection during the first year after randomization (yes/no per patient). Endpoint will be determined by chart review by the Study Coordinator, with consultation with the Site Investigator as needed to confirm that the new course of treatment is directed toward continued or recurrent osteomyelitis of the initially affected lower extremity. The new course will require there be at least a 14 day interval between the end of the initial back-bone antibiotic therapy course. |
Assessed 2 years post intervention
|
Quality of Life - SF-36
Time Frame: Assessed 12 months post intervention
|
Quality of life, measured by the 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992) and its physical and mental health subscales. This is a widely used self-report instrument that will be administered by the Study Coordinator at baseline, 3-, 6- and 12-months. |
Assessed 12 months post intervention
|
Ambulatory Status
Time Frame: Assessed 12 months post intervention
|
Ambulatory status, measured by the Study Coordinator, using a modified item from the Amputee Mobility Predictor Questionnaire56. The patient's "usual method of ambulation within the home" will be assessed by a single self-report item at baseline, 3-, 6- and 12-months using the following response categories:
|
Assessed 12 months post intervention
|
Incidence of Falls
Time Frame: Assessed 12 months post intervention
|
Incidence of falls, measured by self-reported frequency of falls and falls that required medical attention in the one-month periods preceding research visits at Baseline, 3-, 6- and 12-months.
|
Assessed 12 months post intervention
|
Incidence of adverse events related to direct toxicity of rifampin
Time Frame: Assessed 3 months post intervention
|
Incidence of adverse events related to direct toxicity of rifampin in active drug vs. placebo groups:
|
Assessed 3 months post intervention
|
Incidence of adverse events from drug interactions
Time Frame: Assessed 3 months post intervention
|
Incidence of adverse events from drug interactions in active drug vs. placebo groups:
|
Assessed 3 months post intervention
|
Comparative dropout
Time Frame: Assessed 6 weeks post intervention
|
Overall comparative dropout data during the 6-week intervention based on drug intolerance/drug interactions/adverse events in active drug vs. placebo groups. Dropout endpoint will be determined by chart review by the Study Coordinator and by telephone calls to the subject. |
Assessed 6 weeks post intervention
|
Remission of osteomyelitis
Time Frame: Assessed at 1 year post intervention
|
Remission of osteomyelitis at 12 months (yes/no). Remission is defined as epithelialization of any overlying soft tissue defect and the absence of local signs and symptoms of inflammation. Endpoint will be determined by physical examination by the Site Investigator at the 12 month visit. |
Assessed at 1 year post intervention
|
Complete epithelialization of the wound
Time Frame: Assessed 1 year post intervention
|
Complete epithelialization of the wound at 6 weeks and at 3, 6 and 12 months (yes/no). Endpoint will be determined by physical examination by the Site Investigator at the 3, 6 and 12 month visits. |
Assessed 1 year post intervention
|
First occurrence of ipsilateral amputation related to index osteomyelitis
Time Frame: Assessed 2 years post intervention
|
Time from randomization to the first occurrence of ipsilateral amputation for the treatment of osteomyelitis related to the index osteomyelitis. Relatedness will be determined by the LSI or qualified Co-investigator on thePrimary Outcome case report form. An episode of ipsilateral osteomyelitis is considered related to the index osteomyelitis if it involves the same bone or a contiguous bone. |
Assessed 2 years post intervention
|
Collaborators and Investigators
Investigators
- Study Chair: Mary T Bessesen, MD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Infectious
- Osteomyelitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Photosensitizing Agents
- Dermatologic Agents
- Micronutrients
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Vitamins
- Cytochrome P-450 CYP3A Inducers
- Vitamin B Complex
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Rifampin
- Riboflavin
Other Study ID Numbers
- 2001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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