Status:
WITHDRAWN
A RCT of Prednisone as Adjunctive Therapy for Hospitalized Patients With Pulmonary TB and HIV Co-infection
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Ontario Lung Association
Conditions:
Tuberculosis
HIV Infections
Eligibility:
All Genders
17+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if 30-day survival will be improved with addition of prednisone to standard tuberculosis (TB) therapy.
Detailed Description
Tuberculosis (TB) is the leading cause of death in people infected with HIV worldwide. South Africa has one of the highest rates of tuberculosis and HIV in sub Saharan Africa and the world. Infection ...
Eligibility Criteria
Inclusion
- Newly diagnosed AFB smear positive pulmonary TB (via microscopy)
- must be on quadruple standard chemotherapy for TB
- patients admitted to the medical ward (Edendale Hospital (EDH)- Pietermaritzburg,KwaZulu Natal, South Africa)
- must survive the first 24 hours after admission. In addition it takes up to 24 hours for the lab to assess all of the sputum samples sent for analysis
- patients must live in Pietermaritzburg in order to ensure efficient follow up
- positive HIV test (new or documented serodiagnosis via HIV antibody testing (ELISA Bio-rad ACCESS HIV 1/2 Immunoassay System))\*
- adults \>17 yrs of age
- consent to enter study \* Only a screening test will be done to identify HIV positive patients, as the high prevalence of HIV in patients with pulmonary TB (60%) results in a very high positive predictive value, and a Western blot would not be needed as a confirmatory test.
Exclusion
- TB meningitis \*
- TB pericarditis \*
- adrenal Insufficiency \*
- old tuberculosis (Treatment for \> 1 month prior to admission, Treatment failure) or known MDR-TB
- significant co-morbidities such as diabetes, uncontrolled HTN, peptic ulcer disease and renal disease and palliative conditions (untreatable cancer), or another infection
- other serious HIV related diseases such as cryptococcal meningitis, and Non Hodgkin's Lymphoma
- pregnancy
- previously treated with corticosteroids in the last month prior to admission, (9) other pulmonary pathogens identified in sputum 10) allergy to co-trimoxazole) (refer to co-trimoxazole section) \*Based on clinical evaluation these patients will be excluded because evidence exists for using steroids in these conditions.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00414414
Start Date
February 1 2007
End Date
June 1 2009
Last Update
April 4 2017
Active Locations (2)
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1
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
2
Erendale Hospital
Pietermaritzburg, KwaZulu-Natal, South Africa