Trial Outcomes & Findings for Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis (NCT NCT00728507)
NCT ID: NCT00728507
Last Updated: 2017-04-20
Results Overview
LJ culture conversion
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Week 8
Results posted on
2017-04-20
Participant Flow
Participant milestones
| Measure |
HPZM
Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects \<= 45kg and 450mg for those \>45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
|
HRZE
Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
59
|
|
Overall Study
COMPLETED
|
60
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis
Baseline characteristics by cohort
| Measure |
HPZM
n=62 Participants
Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects \<= 45kg and 450mg for those \>45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
|
HRZE
n=59 Participants
Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=93 Participants
|
30 years
n=4 Participants
|
32 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
62 participants
n=93 Participants
|
59 participants
n=4 Participants
|
121 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: modified intention to treat population
LJ culture conversion
Outcome measures
| Measure |
HPZM
n=60 Participants
Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects \<= 45kg and 450mg for those \>45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
|
HRZE
n=51 Participants
Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment
|
|---|---|---|
|
To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy.
|
78.3 percentage of participants
|
84.3 percentage of participants
|
PRIMARY outcome
Timeframe: Weekly or more frequentStudy was prematurely terminated and data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
HPZM
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
HRZE
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HPZM
n=62 participants at risk
Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects \<= 45kg and 450mg for those \>45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
|
HRZE
n=59 participants at risk
Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment
|
|---|---|---|
|
General disorders
flu-like syndrome
|
3.2%
2/62
|
0.00%
0/59
|
|
Eye disorders
change in visual refraction
|
3.2%
2/62
|
1.7%
1/59
|
|
Skin and subcutaneous tissue disorders
rash
|
1.6%
1/62
|
0.00%
0/59
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/62
|
1.7%
1/59
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/62
|
1.7%
1/59
|
|
Hepatobiliary disorders
hepatotoxicity
|
0.00%
0/62
|
5.1%
3/59
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place