Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-31 @ 8:46 PM
Study NCT ID:
NCT00127504
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2005-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009855', 'term': 'Onchocerciasis'}], 'ancestors': [{'id': 'D005368', 'term': 'Filariasis'}, {'id': 'D017205', 'term': 'Spirurida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2005-08-04', 'studyFirstSubmitQcDate': '2005-08-04', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months'}], 'secondaryOutcomes': [{'measure': 'Elimination of microfilaria in skin snips and histological examination of worms after 9 months'}]}, 'conditionsModule': {'keywords': ['Onchocerciasis', 'Wolbachia', 'Therapy'], 'conditions': ['Onchocerciasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).', 'detailedDescription': 'Mass treatment with ivermectin (Mectizan, Merck \\& Co) is the mainstay of the current efforts to control onchocerciasis, but the drug is not lethal to adult Onchocerca volvulus parasites. Wolbachia, an endosymbiotic bacterium necessary for the fecundity of O. volvulus, can be eradicated with four-six week courses of doxycycline, but this cannot be implemented in current mass drug administration programs. The purpose of this study is to evaluate if a shorter course (five days) with antibiotics that could be used in children and potentially pregnant women would likewise be effective.\n\nGuatemalan patients with onchocercal nodules will be enrolled in an open label trial with four treatment groups: Group A (rifampin 20 mg/kg by mouth \\[po; maximum 600 mg/day\\]); B (azithromycin 12 mg/kg po \\[maximum 500 mg/day\\]); C (combination of rifampin 20 mg/kg po \\[maximum 600 mg/day\\] and azithromycin 12 mg/kg po \\[maximum 500 mg/day\\]); D (control group, multivitamin). At the end of the five day treatment course all participants will receive a single dose of ivermectin (150 mcg/kg).\n\nNodulectomies will be performed 9 months after treatment and the O. volvulus will be analyzed by immunohistochemical staining specific for Wolbachia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and non-pregnant/non lactating females \\>5 years of age\n* One onchocercal nodule in an anatomical position where it can be easily removed surgically\n\nExclusion Criteria:\n\n* Pregnancy (based on urine pregnancy test)\n* Breast-feeding\n* Women taking oral contraceptives\n* Allergy or other adverse reaction to either medication\n* Use of other medications that might interact with rifampin\n* Clinical evidence of liver disease (jaundice, swollen abdomen)\n* Clinical evidence of chronic disease/alcoholism'}, 'identificationModule': {'nctId': 'NCT00127504', 'briefTitle': 'Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala', 'orgStudyIdInfo': {'id': 'CDC-NCID-3843'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rifampin', 'type': 'DRUG'}, {'name': 'Azithromycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Universidad del Valle/MERTU', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}], 'overallOfficials': [{'name': 'Josef Amann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CDC/NCID/DPD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Universidad del Valle, Guatemala', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}]}}}