NCT00414414

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2007

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 4, 2017

Status Verified

August 1, 2010

Enrollment Period

2.3 years

First QC Date

December 19, 2006

Last Update Submit

March 31, 2017

Conditions

TuberculosisHIV Infections

Keywords

TBTuberculosisHIVCo-infectionSteroidPrednisoneoral corticosteroidsTB TreatmentSouth Africa

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Secondary Outcomes (1)

  • Our secondary endpoints will involve the measurement of clinical, laboratory and radiological parameters and adverse reactions.

    30 days

Study Arms (2)

prednisone

ACTIVE COMPARATOR
Drug: Prednisone

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

PrednisoneDRUG
Also known as: non applicable
prednisone
placeboDRUG

placebo

Also known as: non applicable
placebo

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Erendale Hospital

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

MeSH Terms

Conditions

TuberculosisHIV InfectionsCoinfection

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Gonzalo Alvarez, MD

    Ottawa Hospital Research Institute

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Study Start

February 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 4, 2017

Record last verified: 2010-08

Locations

CA(1)ZA(1)