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Trial record 73 of 76 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate"

Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis

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ClinicalTrials.gov Identifier: NCT00728507
Recruitment Status : Terminated (Funding withdrawn)
First Posted : August 5, 2008
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tuberculosis
Interventions Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid
Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HPZM HRZE
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 62 59
Completed 60 51
Not Completed 2 8
Arm/Group Title HPZM HRZE Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 62 59 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 62 participants 59 participants 121 participants
33
(25 to 48)
30
(24 to 45)
32
(24 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
Female
47
  75.8%
36
  61.0%
83
  68.6%
Male
15
  24.2%
23
  39.0%
38
  31.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 62 participants 59 participants 121 participants
62 59 121
1.Primary Outcome
Title To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy.
Hide Description LJ culture conversion
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
modified intention to treat population
Arm/Group Title HPZM HRZE
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 60 51
Measure Type: Number
Unit of Measure: percentage of participants
78.3 84.3
2.Primary Outcome
Title To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens.
Hide Description Study was prematurely terminated and data was not collected for this outcome measure.
Time Frame Weekly or more frequent
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPZM HRZE
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HPZM HRZE
Hide Arm/Group Description

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.

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

All-Cause Mortality
HPZM HRZE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HPZM HRZE
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/59 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
HPZM HRZE
Affected / at Risk (%) Affected / at Risk (%)
Total   5/62 (8.06%)   6/59 (10.17%) 
Blood and lymphatic system disorders     
anemia  0/62 (0.00%)  1/59 (1.69%) 
Eye disorders     
change in visual refraction  2/62 (3.23%)  1/59 (1.69%) 
Gastrointestinal disorders     
nausea  0/62 (0.00%)  1/59 (1.69%) 
General disorders     
flu-like syndrome  2/62 (3.23%)  0/59 (0.00%) 
Hepatobiliary disorders     
hepatotoxicity  0/62 (0.00%)  3/59 (5.08%) 
Skin and subcutaneous tissue disorders     
rash  1/62 (1.61%)  0/59 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Susan Dorman
Organization: Johns Hopkins University
Phone: 410-955-1755
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00728507     History of Changes
Other Study ID Numbers: 06-0018
First Submitted: July 30, 2008
First Posted: August 5, 2008
Results First Submitted: August 3, 2016
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017