A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,400

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

February 28, 2014

Study Completion Date

August 31, 2014

Conditions
Tuberculous Pericarditis
Interventions
DRUG

Prednisolone

Prednisolone and placebo will be supplied as 5 mg identical tablets and given at a dosage of 120 mg/day in the first week, followed by 90 mg/day in the second week, 60 mg/day in the third week, 30 mg/day in the fourth week, 15 mg/day in the fifth week, and 5 mg/day in the sixth week.

BIOLOGICAL

Mycobacterium w immunotherapy

Patients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months). Patients in the control arm of the Mycobacterium w comparison will receive a similar regime of placebo injections of normal saline in identically-packaged vials.

Trial Locations (1)

7925

Groote Schuur Hospital, Cape Town

Sponsors
All Listed Sponsors
collaborator

Population Health Research Institute

OTHER

lead

University of Cape Town

OTHER

NCT00810849 - A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis | Biotech Hunter | Biotech Hunter