Back to resultsA RCT of Prednisone as Adjunctive Therapy for Hospitalized Patients With Pulmonary TB and HIV Co-infection
Primary Purpose
Tuberculosis, HIV Infections
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Prednisone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring TB, Tuberculosis, HIV, Co-infection, Steroid, Prednisone, oral corticosteroids, TB Treatment, South Africa
Eligibility 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.
Sites / Locations
- The Ottawa Hospital - General Campus
- Erendale Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
prednisone
placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Our secondary endpoints will involve the measurement of clinical, laboratory and radiological parameters and adverse reactions.
Full Information
NCT ID
NCT00414414
First Posted
December 19, 2006
Last Updated
March 31, 2017
Sponsor
Ottawa Hospital Research Institute
Collaborators
Ontario Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT00414414
Brief Title
A RCT of Prednisone as Adjunctive Therapy for Hospitalized Patients With Pulmonary TB and HIV Co-infection
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not awarded
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Ontario Lung Association
4. Oversight
5. Study Description
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 with HIV can result in activation of the latent form of TB to its active form. In places like sub Saharan Africa where the HIV rates are very high TB has spread with incredible vigor. In order to study this phenomenon, we conducted a preliminary project, which demonstrated that there are approximately 250 patients with active TB admitted to one urban South African hospital in one month and that almost half of them are infected with HIV. One quarter of them died while in hospital. They were young people with an average of 32 years. We are interested in undertaking clinical trials that will study novel therapies that can be added to the existing antimicrobial regimens in order to reduce the number of people dying from TB. One of these therapies would be the addition of prednisone, an oral steroid, to the standard TB treatment regimen. Steroids have been shown to be useful in TB meningitis and pericarditis in HIV positive and negative patients. However, steroids have never been tested in a formal manner in HIV patients with pulmonary TB. We have chosen to do our research in South Africa since the numbers of patients needed to design a clinical trial such as the one presented can only be found in such an environment. Prednisone is cheap, easily obtainable and thus a sustainable intervention in developing countries. The impact of the research would affect not only the international community including Canada but would certainly have a lasting sustainable effect on the local community in Pietermaritzburg, South Africa in addition to the rest of the world.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV Infections
Keywords
TB, Tuberculosis, HIV, Co-infection, Steroid, Prednisone, oral corticosteroids, TB Treatment, South Africa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prednisone
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
non applicable
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
non applicable
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Our secondary endpoints will involve the measurement of clinical, laboratory and radiological parameters and adverse reactions.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo Alvarez, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Erendale Hospital
City
Pietermaritzburg
State/Province
KwaZulu Natal
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
A RCT of Prednisone as Adjunctive Therapy for Hospitalized Patients With Pulmonary TB and HIV Co-infection
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