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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00414414
• Date of registration: 19/12/2006
• Prospective Registration: Yes
• Primary sponsor: Ottawa Hospital Research Institute
• Public title: A RCT of Prednisone as Adjunctive Therapy for Hospitalized Patients With Pulmonary TB and HIV Co-infection
• Scientific title: A Randomized, Prospective Double Blind Placebo Control Clinical Trial of Prednisone as Adjunctive Therapy for the Treatment of Hospitalized Patients With Pulmonary TB and HIV Co-infection
• Date of first enrolment: February 2007
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00414414
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Canada, South Africa

Contacts

• Name: Gonzalo Alvarez, MD
• Affiliation: Ottawa Hospital Research Institute

Key inclusion & exclusion 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.



Age minimum: 17 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

HIV Infections

Intervention(s)

Drug: Prednisone

Drug: placebo

Primary Outcome(s)

Our primary objective is to determine if 30-day survival will be improved with addition of prednisone to quadruple standard TB therapy. We will measure all cause mortality at 30 days. [Time Frame: 30 days]

Secondary Outcome(s)

Our secondary endpoints will involve the measurement of clinical, laboratory and radiological parameters and adverse reactions. [Time Frame: 30 days]

Secondary ID(s)

2006301-01H

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ontario Lung Association