Trial Outcomes & Findings for Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis (NCT NCT00082173)

NCT ID: NCT00082173

Last Updated: 2013-05-22

Results Overview

Proportion of patients with sterile sputum cultures

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 170 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2013-05-22

Participant Flow

Subjects with respiratory symptoms suggestive of TB were recruited from the HUCFF outpatient TB clinic as well as other local TB clinics.

Patients who did not meet enrollment criteria or who did not want to participate in the study were excluded.

Participant milestones

Measure	Experimental Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks	Control Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Overall Study STARTED	74	72
Overall Study COMPLETED	64	61
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Measure	Experimental Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks	Control Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Overall Study Withdrawal by Subject	3	5
Overall Study Lost to Follow-up	1	0
Overall Study Adverse Event	1	0
Overall Study Culture negative or resistant at baselin	5	6

Baseline Characteristics

Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

Baseline characteristics by cohort

Measure	Experimental Arm (Moxi) n=74 Participants	Control Arm (EMB) n=72 Participants	Total n=146 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age Continuous	32.5 years STANDARD_DEVIATION 11.7 • n=5 Participants	35.7 years STANDARD_DEVIATION 12.0 • n=7 Participants	34.1 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	22 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	50 Participants n=7 Participants	90 Participants n=5 Participants
Region of Enrollment Brazil	74 participants n=5 Participants	72 participants n=7 Participants	146 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Proportion of patients with sterile sputum cultures at week 8

Proportion of patients with sterile sputum cultures

Outcome measures

Measure	Experimental Arm n=64 Participants INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks	Control Arm n=61 Participants INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Proportion of Patients With Sterile Sputum Cultures	59 Participants	45 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: DAIDS Table of Adverse Events

Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications

Outcome measures

Measure	Experimental Arm n=74 Participants INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks	Control Arm n=72 Participants INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications	0 Participants	0 Participants

Adverse Events

Experimental Arm

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental Arm n=74 participants at risk INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks	Control Arm n=72 participants at risk INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
General disorders Hospitalization	4.1% 3/74 • Number of events 4 • 18 months	4.2% 3/72 • Number of events 3 • 18 months
Cardiac disorders Death	4.1% 3/74 • Number of events 3 • 18 months	6.9% 5/72 • Number of events 5 • 18 months
Renal and urinary disorders Grade 4 event	1.4% 1/74 • Number of events 1 • 18 months	0.00% 0/72 • 18 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Chaisson

Johns Hopkins University

Phone: 410-955-1755

Email: rchaiss@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place