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Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis Clinical research trials and Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis. Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis clinical trial. Human subjects often get the best healthcare possible for their Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis  Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
For Condition: Tuberculosis
Status: Not yet recruiting
Sponsor(s): Food and Drug Administration (FDA) ,
Synopsis: Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.
Details: Approximately one-third of the world’s population is infected with Mycoplasma tuberculosis; 7 to 8 million new cases of active TB occur each year. TB is the second most common infectious cause of death worldwide. Appropriate treatment of persons with active TB is very important in limiting the transmission of M. tuberculosis and preventing TB-related mortality. Current therapy requires 6 months of a four-drug regimen of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and EMB. The development of alternative regimens is a priority, and new classes of antituberculosis agents are needed to provide treatment options for patients with drug-resistant disease. This study will evaluate the effectiveness of replacing EMB with MOX in a multi-drug regimen in the initial phase of treatment of smear-positive pulmonary TB in patients with and without HIV infection. Participants in this study will be randomly assigned to receive either a MOX-containing drug regimen or the standard EMB-containing drug regimen for 8 weeks. Participants will have study visits weekly during these 8 weeks. After 8 weeks, participants will discontinue MOX, EMB, and PZA and will continue taking INH and RFP for 4 months. Participants will have study visits at Months 4, 6, 12, and 18. Study visits will include a medical interview, physical exam, blood and urine tests, and sputum tests for TB.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry. Patients with both pulmonary and extrapulmonary disease are eligible. - Documentation of HIV infection status. If HIV status is unknown at study entry, the participant must consent to testing and results must be available prior to study participation. - Agree to use acceptable methods of contraception Exclusion Criteria: - History of adverse drug reaction to MOX, INH, RIF, PZA, or EMB - Disease or condition for which MOX, INH, RIF, PZA, or EMB is contraindicated - History of more than 14 days of continuous antituberculosis therapy during the previous 2 years or more than 2 months of antituberculosis therapy ever - Active AIDS-related opportunistic infection or malignancy - Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 2 months after study entry - Silicotuberculosis - Central nervous system TB - Pregnant or breastfeeding - Unable to take oral medication - Electrocardiogram (EKG) QTc interval greater than 450 msec - Taking classes IA or III antiarrhythmic agents (quinidine, procainamide, amiodarone, sotalol), cisapride, erythromycin, perphenazine/amitriptyline, phenothiazines, or tricyclic antidepressant - Diseases or conditions for which treatment with other drugs with antituberculosis activity (e.g., rifabutin for MAC prophylaxis) is anticipated during the course of the study
Total Enrollment: 170
Location and Contact Information:
Overall Study Official:
RichardChaisson, Principal Investigator, Johns Hopkins University
Clementino Fraga Filho Hospital
Rio de Janeiro, ,
Brazil
Marcus Conde + 55 21 2562 2426
Additional Information:
Study ID Numbers: FD-R-002135-01;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082173
Other Tuberculosis Studies:
1. Tuberculosis in HIV Infected Patients in Uganda
2. A Non-Comparative Study of the Efficacy of a Largely-Intermittent, Six-Month Tuberculosis Treatment Regimen Among Patients Who Will Not Receive Isoniazid Due to Initial Isoniazid Resistance or Intolerance
3. Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients with Tuberculosis
4. Diagnosing Tuberculosis in HIV Infected Children in Peru
5. A Registry of Tuberculosis Cases in the CPCRA
Related Studies:
Other Tuberculosis Clinical Trials
Other Clinical Trials
Other Rio de Janeiro Clinical Trials
Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
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