A RCT of Prednisone as Adjunctive Therapy for Hospitalized Patients With Pulmonary TB and HIV Co-infection

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: Ontario Lung Association
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.