Pneumocystis Jirovecii PneumoniaNCT04328688
Clindamycin-trimethoprim/Sulfamethoxazole for PCP After Solid Organ Transplantation Population.
An observational study of Pneumocystis Jirovecii Pneumonia and Solid Organ Transplantation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumocystis Jirovecii Pneumonia, Solid Organ Transplantation
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Sep 2019
- How long will I take part?
- 60 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- PJP after solid organ transplantation.
Who cannot join
- renal failure,heart failure,tumor recurrence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- TMP-SMX, clindamycin, oxygenation index, adverse reactions
- Medical subject headings
- Pneumonia, Pneumocystis
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation index
PaO2/FiO2
Measured: through study completion, an average of 20 days
length of ICU stay
Total length of stay in ICU
Measured: through study completion, an average of 20 days
Secondary outcomes (1)
adverse reactions of drugs
Rash，Anorexia，Decreased white blood cell count，Anemia，Decreased platelet count，Increased TB，Increased creatinine，Hyperkalemia
Measured: through study completion, an average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Sep 2017
- Primary completion1 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumocystis Jirovecii PneumoniaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328688
- Sponsor's protocol ID
- CTSTOP
- Status last verified
- Mar 2020
- First submitted
- 2 Jan 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35602475
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clindamycin - Trimethoprim/Sulfamethoxazole for Pneumocystis Jiroveci Pneumonia After Solid Organ Transplantation Population (CTSTOP)
- ClinicalTrials.gov ID
- NCT04328688
- Acronym / sponsor ID
- CTSTOP
- Keywords
- TMP-SMX, clindamycin, oxygenation index, adverse reactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 60 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- PJP after solid organ transplantation.
Key exclusion criteria (1 listed)
- renal failure,heart failure,tumor recurrence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oxygenation index
Time frame: through study completion, an average of 20 days
PaO2/FiO2
length of ICU stay
Time frame: through study completion, an average of 20 days
Total length of stay in ICU
1 secondary outcome
adverse reactions of drugs
Time frame: through study completion, an average of 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 35602475Gu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumocystis Jirovecii Pneumonia and Solid Organ Transplantation, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation index (time frame: through study completion, an average of 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.