Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT00216333
Status:
UNKNOWN
Last Update Posted:
2006-09-13
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-06'}, 'lastUpdateSubmitDate': '2006-09-12', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.'}, {'measure': 'Safety : occurrence of serious adverse events at any time during chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Sputum culture results at two months of chemotherapy'}, {'measure': 'Rate of completion of chemotherapy according to the protocol'}]}, 'conditionsModule': {'keywords': ['tuberculosis', 'fixed dose combination', 'DOT', 'shot-course chemotherapy'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '21486974', 'type': 'DERIVED', 'citation': 'Lienhardt C, Cook SV, Burgos M, Yorke-Edwards V, Rigouts L, Anyo G, Kim SJ, Jindani A, Enarson DA, Nunn AJ; Study C Trial Group. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial. JAMA. 2011 Apr 13;305(14):1415-23. doi: 10.1001/jama.2011.436.'}]}, 'descriptionModule': {'briefSummary': 'The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.', 'detailedDescription': 'This is a multiple country, multicenter study, using the parallel group open-label randomised trial design. The primary objective of this investigation is to assess the efficacy, acceptability and toxicity of a combined FDC regimen of chemotherapy in patients with newly diagnosed smear positive pulmonary tuberculosis in comparison with the standard regimen using separate drugs.\n\nPatients will be allocated at random either :\n\n* an initial intensive phase of eight weeks of daily ethambutol, isoniazid, rifampicin and pyrazinamide, in a fixed dose COMBINED tablet, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet three times a week (2COMB/4(RH)3) or\n* the same drugs given in SEPARATE formulations in the initial intensive phase of eight weeks, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet, three times a week (2SEPA/4(RH)3)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed pulmonary tuberculosis\n* two sputum specimens positive for acid-fast bacilli on direct smear microscopy\n* no previous anti-tuberculosis chemotherapy\n* aged 18 years and over\n* firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)\n* agree to participate in the study and to give a sample of blood for HIV test\n\nExclusion Criteria:\n\n* patients in a moribund state,\n* TB meningitis,\n* pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,\n* pregnancy or breast feeding,\n* psychiatric illness\n* alcoholism\n* contraindication to any medications in the study regimens'}, 'identificationModule': {'nctId': 'NCT00216333', 'briefTitle': 'Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'International Union Against Tuberculosis and Lung Diseases'}, 'officialTitle': 'International Multicenter Trial for the Evaluation of a Four-Drug Fixed Dose Combined Tablet Daily in the Initial Intensive Phase of Chemotherapy Followed by a Two-Drug Fixed Dose Combined Tablet Three Times a Week in the Continuation Phase for the Treatment of Pulmonary Tuberculosis', 'orgStudyIdInfo': {'id': 'IUATLD CT Study C'}}, 'armsInterventionsModule': {'interventions': [{'name': 'combined fixed dose combination', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Algiers', 'status': 'NOT_YET_RECRUITING', 'country': 'Algeria', 'contacts': [{'name': 'Noureddine Zidouni, MD', 'role': 'CONTACT', 'email': 'nzidouni@sante.dz', 'phone': '213-21 93 13 86'}, {'name': 'Noureddine Zidouni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Pneumo-phtisiologie de Matiben', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'city': 'Santa Cruz', 'status': 'RECRUITING', 'country': 'Bolivia', 'contacts': [{'name': 'Mirtha Camacho, MD', 'role': 'CONTACT', 'email': 'tbcos@hotmail.com', 'phone': '59122211275'}, {'name': 'Segondo Guzman, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Program Nal. de Control de la Tuberculosis', 'geoPoint': {'lat': -21.75, 'lon': -65.31667}}, {'city': 'Cali', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Dr Juan Francisco Miranda, MD', 'role': 'CONTACT', 'email': 'mirandaf@cideim.org.co', 'phone': '57 2 668 2164'}, {'name': 'Gustavo Montero, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centro Internacional de Entrenamiento', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Conakry', 'status': 'RECRUITING', 'country': 'Guinea', 'contacts': [{'name': 'Mamadou D BARRY, MD', 'role': 'CONTACT', 'email': 'mdtelibarry@yahoo.fr', 'phone': '224 29 86 40'}, {'name': 'Boubacar BAH, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Ignace Deen', 'geoPoint': {'lat': 9.53795, 'lon': -13.67729}}, {'city': 'Manhiça', 'status': 'RECRUITING', 'country': 'Mozambique', 'contacts': [{'name': 'Mateu Dr Mateu Espasa, MD', 'role': 'CONTACT', 'email': 'mateu.espasa@manhica.net', 'phone': '+ 258 1 81 01 81'}, {'name': 'Mateu Espasa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Health Resesarch Center of Manhica', 'geoPoint': {'lat': -25.40222, 'lon': 32.80722}}, {'city': 'Kathmandu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Nepal', 'facility': 'Nepal Anti-Tuberculosis Association', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}, {'city': 'Lima', 'status': 'RECRUITING', 'country': 'Peru', 'contacts': [{'name': 'Víctor Manuel Chávez Pérez, MD', 'role': 'CONTACT', 'email': 'chzpz@viabcp.com', 'phone': '+51-1-328-2451'}, {'name': 'Eduardo Ticona, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Grupo Levir S.A.', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Mwanza', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Tanzania', 'facility': 'National Institute for Medical Research', 'geoPoint': {'lat': -2.51667, 'lon': 32.9}}, {'city': 'Hanoi', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Sy Dinh Ngoc, MD, PhD', 'role': 'CONTACT', 'email': 'vnntp463@hn.vnn.vn', 'phone': '0913284158'}, {'name': 'Thuy Ha, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Hospital of TB and Respiratory Diseases', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'centralContacts': [{'name': 'Sharlette Cook, MPH', 'role': 'CONTACT', 'email': 'scook@iuatld.org', 'phone': '+33 1 44 32 06 47'}, {'name': 'Christian Lienhardt, MD', 'role': 'CONTACT', 'email': 'clienhardt@iuatld.org', 'phone': '+ 33 1 44 32 06 43', 'phoneExt': '06 43'}], 'overallOfficials': [{'name': 'Christian Lienhardt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'International Union Against Tuberculosis and Lung Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Union Against Tuberculosis and Lung Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}]}}}