Clindamycin-trimethoprim/Sulfamethoxazole for PCP After Solid Organ Transplantation Population.
Clindamycin - Trimethoprim/Sulfamethoxazole for Pneumocystis Jiroveci Pneumonia After Solid Organ Transplantation Population (CTSTOP)
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedMarch 31, 2020
March 1, 2020
2 years
January 2, 2020
March 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
oxygenation index
PaO2/FiO2
through study completion, an average of 20 days
length of ICU stay
Total length of stay in ICU
through study completion, an average of 20 days
Secondary Outcomes (1)
adverse reactions of drugs
through study completion, an average of 20 days
Eligibility Criteria
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)
You may qualify if:
- PJP after solid organ transplantation.
You may not qualify if:
- renal failure,heart failure,tumor recurrence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ju Minjie
Shanghai, Shanghai Municipality, 200000, China
Related Publications (1)
Gu ZY, Liu WJ, Huang DL, Liu YJ, He HY, Yang C, Liu YM, Xu M, Rong RM, Zhu DM, Luo Z, Ju MJ. Preliminary Study on the Combination Effect of Clindamycin and Low Dose Trimethoprim-Sulfamethoxazole on Severe Pneumocystis Pneumonia After Renal Transplantation. Front Med (Lausanne). 2022 May 6;9:827850. doi: 10.3389/fmed.2022.827850. eCollection 2022.
PMID: 35602475DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 60 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2020
First Posted
March 31, 2020
Study Start
September 1, 2017
Primary Completion
September 1, 2019
Study Completion
September 30, 2019
Last Updated
March 31, 2020
Record last verified: 2020-03