Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-01 @ 6:56 PM
Study NCT ID:
NCT00371995
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2006-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007898', 'term': 'Leishmaniasis, Visceral'}], 'ancestors': [{'id': 'D007896', 'term': 'Leishmaniasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C068538', 'term': 'liposomal amphotericin B'}, {'id': 'C039128', 'term': 'miltefosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2006-09-05', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Final Cure six months after the end of treatment', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Visceral leishmaniasis', 'kala-azar', 'miltefosine', 'AmBisome'], 'conditions': ['Visceral Leishmaniasis']}, 'referencesModule': {'references': [{'pmid': '21129762', 'type': 'RESULT', 'citation': 'Sundar S, Sinha PK, Verma DK, Kumar N, Alam S, Pandey K, Kumari P, Ravidas V, Chakravarty J, Verma N, Berman J, Ghalib H, Arana B. Ambisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg. 2011 Feb;105(2):115-7. doi: 10.1016/j.trstmh.2010.10.008. Epub 2010 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.', 'detailedDescription': 'Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15).\n\nAt two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.\n\nNumber of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-65 years).\n\nLack of suitability for the trial:\n\n* Post Kala-azar Dermal Leishmaniasis (PKDL)\n* Concomitant treatment with other anti-leishmanial drugs\n* Any condition which compromises ability to comply with the study procedures\n\nAdministrative reasons:\n\n* Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication, dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.\n\nMiltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)\n\nDosage:\n\n1. weighing ≥ 25 kg: 100 mg miltefosine daily as one capsule (50 mg) in the morning and one capsule in the evening, after meals for 14 days.\n2. weighing \\< 25 kg: 50 mg miltefosine daily as one capsule (50 mg) in the morning, after meals for 14 days. Parameter for evaluation\n\n * Final cure rate (initial parasite cure and clinical assessment at six month EOT)\n * Initial parasitological cure rate (based on splenic aspirates or Bone marrow aspirate)\n * Clinical response at end of treatment (clinical assessment)\n * Adverse events\n\nStatistical methods\n\n* Calculation of cure rate with 95% and 90% lower confidence limit according to Clopper Pearson\n* Calculation of overall incidence of adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female age between 2 and 65 years (inclusive)\n* Parasites visualized on splenic aspiration\n* Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)\n* Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate\n* Fever for at least 2 weeks\n* Written informed consent from the patient/or from parent or guardian if under 18 years old\n\nExclusion Criteria:\n\n* Hemoglobin \\< 6 g/dl\n* White blood cell count \\< 1000/mm3\n* Platelets \\<50,000\n* Prothrombin time \\> 5 sec above control\n* ASAT \\> 3 times the upper limit of normal\n* Serum creatinine or BUN \\> 1.5 times the upper limit of normal\n* Malaria\n* Tuberculosis\n* HIV positive serology\n* Lactation, pregnancy\n* Refusing contraception method during treatment period plus 3 months\n* Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs\n* Any concomitant drug that is nephrotoxic'}, 'identificationModule': {'nctId': 'NCT00371995', 'briefTitle': 'Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar', 'organization': {'class': 'OTHER', 'fullName': 'Banaras Hindu University'}, 'officialTitle': 'The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India', 'orgStudyIdInfo': {'id': 'LEI PDE 06 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.\n\nMiltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)', 'interventionNames': ['Drug: Liposomal amphotericin B and Miltefosine']}], 'interventions': [{'name': 'Liposomal amphotericin B and Miltefosine', 'type': 'DRUG', 'otherNames': ['AmBisome and Impavido'], 'description': 'Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.\n\nMiltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '842001', 'city': 'Muzaffarpur', 'state': 'Bihar', 'country': 'India', 'facility': 'Kala-azar Medical Research Center', 'geoPoint': {'lat': 26.12259, 'lon': 85.39055}}, {'city': 'Patna', 'state': 'Bihar', 'country': 'India', 'facility': 'Rajendra Memorial Research Institute of Medical Sciences', 'geoPoint': {'lat': 25.59408, 'lon': 85.13563}}], 'overallOfficials': [{'name': 'Shyam Sundar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Banaras Hindu University'}, {'name': 'Prabhat K Sinha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rajendra Memorial Research Institute of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Banaras Hindu University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rajendra Memorial Research Institute of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Shyam Sundar, Professor', 'oldOrganization': 'Banaras Hdindu University'}}}}