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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00425113 |
Purpose
This study will evaluate the effect of adding metronidazole to standard second-line therapy for tuberculosis in patients who have multi-drug resistant tuberculosis (MDR-TB) of the lungs. It will evaluate the safety and tolerability of metronidazole in combination with antituberculosis agents.
Metronidazole is a drug widely used to treat bacterial and parasitic infections occurring in environments with very little oxygen such as the human colon. Nine million new cases of sputum-positive tuberculosis are diagnosed worldwide each year.
Patients ages 20 and older who have symptoms of TB, who have been treated for tuberculosis but whose disease is multi-drug resistant, and who are not pregnant or breast feeding may be eligible for this study. They will be recruited in the National Masan Tuberculosis Hospital (NMTH), Masan, Republic of
Korea. Patients will undergo the following tests and procedures:
Patients will receive either an 8-week course of standard second-line agents plus placebo (sugar pill) or an 8-week course of standard agents plus metronidazole. The subjects, doctors and researchers will not know which patients are taking the metronidazole until after the first 2 years of the trial. A total of 60 patients will be assigned to two cohorts of 30 patients each. After 8 weeks, all patients will return to the standard of care chemotherapy, according to normal procedures at NMTH.
Side effects of metronidazole commonly reported are vaginal discharge, symptoms of Candida cervicitis and vaginitis, headache, nausea and vomiting, and dizziness. Peripheral neuropathy, an abnormal condition of the nerves, may also be a side effect. The precise incidence of neuropathy is unknown but is usually related to the duration of metronidazole use. It can almost always be reversed when the drug is discontinued. Serious side effects, though rare, may include leukopenia and thrombocytopenia (disorders in the blood), seizures and other central nervous system problems, and hepatitis.
This study may or may not have a direct benefit for participants. However, it is possible that patients' drug-resistant disease may be more effectively treated as a result of metronidazole. The study may help identify new methods for measuring drug effectiveness during TB studies.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis Multi-Drug Resistant Tuberculosis |
Drug: Metronidazole Procedure: Blood Draw Procedure: CT Scan Procedure: PET Scan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Metronidazole Combined With Antituberculous Chemotherapy vs. Antituberculous Chemotherapy With Placebo in Subjects With Multi-Drug Resistant Pulmonary Tuberculosis |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
People with any of the following in their current medical assessment:
The use of any of the following drugs within 30 days prior to study or anticipated use of these drugs within the next 60 days:
Contacts and Locations| Contact: Laura E. Via, Ph.D. | (301) 451-9554 | lvia@niaid.nih.gov |
| Korea, Republic of | |
| National Masan Tuberculosis Hospital | Recruiting |
| Masan, Korea, Republic of | |
| Yonsei University College of Medicine | Recruiting |
| Seoul, Korea, Republic of | |
More Information
| Responsible Party: | National Institutes of Health ( Clifton E. Barry III, Ph.D./National Institute of Allergy and Infectious Diseases ) |
| Study ID Numbers: | 999907041, 07-I-N041 |
| Study First Received: | January 19, 2007 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00425113 History of Changes |
| Health Authority: | United States: Federal Government |
|
Mycobacterium Tuberculosis Anaerobic FDG-PET-HRCT HRCT |
Lesion Matrix Tuberculosis TB |
|
Bacterial Infections Metronidazole Gram-Positive Bacterial Infections Radiation-Sensitizing Agents Respiratory Tract Infections Respiratory Tract Diseases |
Tuberculosis, Multidrug-Resistant Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis |
|
Bacterial Infections Anti-Infective Agents Metronidazole Antiprotozoal Agents Tuberculosis, Multidrug-Resistant Physiological Effects of Drugs Pharmacologic Actions Actinomycetales Infections Antiparasitic Agents |
Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Radiation-Sensitizing Agents Therapeutic Uses Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis |