Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis... | NCT01747278

Studies
Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

NCT01747278

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Dec 11, 2012Estimated

Enrollment

80Estimated

Phase

Phase 2Phase 3

Conditions

Pneumonia, Pneumocystis
Prevention & Control

Interventions

Trimethoprim/Sulfamethoxazole

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jun 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Dec 9, 2012

First Submission Date that Met QC Criteria

Dec 9, 2012

First Posted Date

Dec 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2012

Last Update Posted Date

Dec 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fengchun Zhang, Professor, Peking Union Medical College HospitalPrincipal Investigator

Lead Sponsor

Peking Union Medical College HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. Observation period of 12 weeks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Trimethoprim/Sulfamethoxazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trimethoprim/Sulfamethoxazole	Drug	Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.	TMP/SMX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 weeks.

Secondary Outcomes

Measure	Description	Time Frame
PCP-related mortality	PCP-related mortality at the end of week 12.	12 weeks
All cause mortality	All cause mortality at the end of week 12.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
concomitant antibiotics other than trimethoprim/sulfamethoxazole
Patient with malignancy
Drug allergy, especially trimethoprim/sulfamethoxazole

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hua Chen, MD	Contact	+86-10-69158797		chenhua@pumch.cn

Overall Officials

Name	Affiliation	Role
Fengchun Zhang, MD	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deptment of Rheumatology, Peking Union Medical College Hospital	Recruiting	Beijing		100032	China

Condition Browse Module

MeSH Terms

ID	Term
D011020	Pneumonia, Pneumocystis

Ancestor Terms

ID	Term
D008172	Lung Diseases, Fungal
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015662	Trimethoprim, Sulfamethoxazole Drug Combination

Ancestor Terms

ID	Term
D013420	Sulfamethoxazole
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides

Browse Leaves

Not provided

Browse Branches

Not provided