TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
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Purpose
This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of daily therapy) during the first two months of standard treatment (with isoniazid, rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis, Pulmonary |
Drug: moxifloxacin (with isoniazid, rifampin, pyrazinamide) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | TBTC Study 27: An Evaluation of the Activity and Tolerability of Moxifloxacin During the First Two Months of Treatment for Pulmonary Tuberculosis--A Double-Blind, Randomized, Multicenter Study by the Tuberculosis Trials Consortium |
- Two-month culture conversion
- Serious Adverse Event
| Estimated Enrollment: | 350 |
| Study Start Date: | July 2003 |
| Study Completion Date: | December 2005 |
The primary objective of this Phase II clinical trial is to compare the safety and microbiological activity of a moxifloxacin-containing regimen (isoniazid, rifampin, pyrazinamide, moxifloxacin [HRZMoxi]) to a control regimen (isoniazid, rifampin, pyrazinamide, ethambutol [HRZE]) in the first two months of treatment of sputum smear-positive pulmonary tuberculosis. In addition, the study will evaluate whether intermittent administration (thrice-weekly after the first 2 weeks) of these regimens affects their tolerability and microbiological activity. The assessment of microbiological activity will be sputum culture-conversion. Improved sputum culture conversion after 2 months of treatment with a moxifloxacin-containing regimen would support phase 3 clinical trials of moxifloxacin in treatment regimens of less than the current 6 month standard regimens.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Suspected pulmonary tuberculosis with acid-fast bacilli in a stained sputum smear – patients whose sputum cultures do not grow M. tuberculosis and those having an M. tuberculosis isolate resistant to rifampin will be discontinued from the study, but followed for 14 days to detect late toxicities from study therapy. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment
- 7 or fewer days of tuberculosis therapy in the 6 months preceding enrollment
- Age > 18 years
- Karnofsky score of at least 60
- Signed informed consent
- Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual sex.
Laboratory parameters within 14 days of enrollment:
- Serum amino aspartate transferase (AST) activity less than 3 times the upper limit of normal
- Serum total bilirubin level less than 2.5 times upper limit of normal
- Serum creatinine level less than 2 times upper limit of normal
- Hemoglobin level of at least 7.0 g/dL
- Platelet count of at least 50,000/mm3
- Serum potassium > 3.0 meq/L
- Negative pregnancy test (for women of childbearing potential)
Exclusion Criteria:
- Breast-feeding
- Known intolerance to any of the study drugs
- Known allergy to any fluoroquinolone antibiotic
- Current or planned therapy during the first 2 months of tuberculosis treatment using drugs having unacceptable interactions with rifampin (rifabutin can be substituted for rifampin during the continuation phase of therapy)
- Current or planned antiretroviral therapy during the first 2 months of tuberculosis treatment
- History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the first 2 months of tuberculosis treatment.
- Pulmonary silicosis
Contacts and Locations
Show 23 Study Locations| Principal Investigator: | William Burman, MD | Denver Public Health Department |
| Principal Investigator: | Richard E Chaisson, MD | Johns Hopkins University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00140309 History of Changes |
| Other Study ID Numbers: | CDC-NCHSTP-3716 |
| Study First Received: | August 30, 2005 |
| Last Updated: | March 16, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Centers for Disease Control and Prevention:
|
TB Pulmonary Tuberculosis Tuberculosis Pulmonary TB |
Additional relevant MeSH terms:
|
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Isoniazid Pyrazinamide Rifampin Moxifloxacin Norgestimate, ethinyl estradiol drug combination Fatty Acid Synthesis Inhibitors |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents Antibiotics, Antitubercular Enzyme Inhibitors Leprostatic Agents Nucleic Acid Synthesis Inhibitors Contraceptives, Oral, Combined Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 23, 2013