Pneumonia, PneumocystisPhase 2/3NCT01747278
Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients
A Phase 2/3 study testing Trimethoprim/Sulfamethoxazole in people with Pneumonia, Pneumocystis and Prevention & Control, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents. Open-labeled, randomized, prospective single-center clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pneumonia, Pneumocystis, Prevention & Control
- What is being tested?
- Trimethoprim/Sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Aug 2013
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years with informed consent
- SLE, Sjögren syndrome, Polymyositis or Dermatomyositis, defined by consensus classification criteria
- concomitant high dose glucocorticoid, defined as >1mg/kg/d prednisone or equivalent
- concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil
Who cannot join
- Pregnant or lactating
- WBC< 4×10^9/L，PLT<100×10^9/L
- Serum ALT or AST > 2 times upper limit of normal
- Serum creatinine > 1.5 mg/dL
- Severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
- Active infection, including HIV, HCV, HBV, tuberculosis or PCP
Show all 9Show fewer
- concomitant antibiotics other than trimethoprim/sulfamethoxazole
- Patient with malignancy
- Drug allergy, especially trimethoprim/sulfamethoxazole
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, 100032
Fengchun Zhang, MD, +86-10-69158794, ZhangFCcra@yahoo.com.cn
Fengchun Zhang, MD
About this study
Official title: The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases
Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents.
Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.
- Conditions
- Pneumonia, Pneumocystis, Prevention & Control
- Being tested
- Trimethoprim/Sulfamethoxazole
- Keywords
- Pneumocystis carinii pneumonia, prophylaxis, trimethoprim/sulfamethoxazole
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim/SulfamethoxazoleDrug
Also called Septra
Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX). |
| TMP/SMX | Experimental | Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis. Receives: Drug: Trimethoprim/Sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented PCP infection
Documented Pneumocystis carinii pneumonia infection: defined as documentation of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PCP.
Measured: 12 weeks.
Secondary outcomes (4)
PCP-related mortality
PCP-related mortality at the end of week 12.
Measured: 12 weeks
All cause mortality
All cause mortality at the end of week 12.
Measured: 12 weeks
Other infections
Infections other than PCP throughout the study period.
Measured: 12 weeks
PCP-related hospitalization
PCP-related hospitalization throughout the study period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PneumocystisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengchun Zhang, Peking Union Medical College Hospital
- Investigators
- Fengchun Zhang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747278
- Sponsor's protocol ID
- PUMCH-CTD-PCP
- Status last verified
- Dec 2012
- First submitted
- 9 Dec 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases
- ClinicalTrials.gov ID
- NCT01747278
- Acronym / sponsor ID
- PUMCH-CTD-PCP
- Conditions
- Pneumonia, Pneumocystis, Prevention & Control
- Keywords
- Pneumocystis carinii pneumonia, prophylaxis, trimethoprim/sulfamethoxazole
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- 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.
Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents.
Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Patients were not treated with Trimethoprim/Sulfamethoxazole (TMP/SMX). |
| TMP/SMX | Experimental | Drug: Trimethoprim/SulfamethoxazolePatients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 80 mg/400 mg p.o. every day as PCP Prophylaxis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years with informed consent
- SLE, Sjögren syndrome, Polymyositis or Dermatomyositis, defined by consensus classification criteria
- concomitant high dose glucocorticoid, defined as >1mg/kg/d prednisone or equivalent
- concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil
Key exclusion criteria (9 listed)
- Pregnant or lactating
- WBC< 4×10^9/L，PLT<100×10^9/L
- Serum ALT or AST > 2 times upper limit of normal
- Serum creatinine > 1.5 mg/dL
- Severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim/SulfamethoxazoleAlso: SeptraOral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks. | Drug | TMP/SMX |
Primary outcome
Documented PCP infection
Time frame: 12 weeks.
Documented Pneumocystis carinii pneumonia infection: defined as documentation of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PCP.
4 secondary outcomes
PCP-related mortality
Time frame: 12 weeks
All cause mortality
Time frame: 12 weeks
Other infections
Time frame: 12 weeks
PCP-related hospitalization
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
Related trials for Pneumonia, Pneumocystis
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
Not yet recruitingObservational study
TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
Enrolling by invitation
Patient-Centered Practical Vaccine Talk For Busy Clinicians
Influenza, COVID-19
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.
Fengchun Zhang, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trimethoprim/Sulfamethoxazole in people with Pneumonia, Pneumocystis and Prevention & Control, run by Peking Union Medical College 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Dec 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Chen, MD (+86-10-69158797, chenhua@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented PCP infection (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2012.