High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 1, 2014

Primary Completion Date

November 5, 2016

Study Completion Date

May 5, 2017

Conditions
Tuberculosis, Meningeal
Interventions
DRUG

Placebo

"Patients receiving 450 mg rifampicin will receive additional 2 placebo tablets, while those who receive 900 mg rifampicin will receive 1 placebo tablet.~Patients receiving 1350 mg rifampicin will not receive any placebo tablet.~With this arrangement, every subject will receive 3 tablets of study drugs."

DRUG

Rifampicin

"Patients in experimental arms will receive either 1 or 2 additional tablets of rifampicin.~Placebo tablets will be added accordingly, so that every study subject will receive 3 tablets of rifampicin plus placebo as described in the Arms section."

DRUG

Other TB drugs

"Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.~Unconscious subjects will receive oral drugs via nasogastric tubes (NGT)"

DRUG

Adjuvant dexamethasone

Patients will receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission)

Trial Locations (1)

40161

Hasan Sadikin General Hospital, Bandung

All Listed Sponsors
collaborator

United States Agency for International Development (USAID)

FED

collaborator

Radboud University Medical Center

OTHER

lead

Universitas Padjadjaran

OTHER

NCT02169882 - High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study | Biotech Hunter | Biotech Hunter