Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01138956
Status:
UNKNOWN
Last Update Posted:
2010-06-08
First Post:
2010-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine
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': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-07', 'studyFirstSubmitDate': '2010-06-07', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient recovery from the visceral leishmaniasis after treatment', 'timeFrame': '6 months', 'description': 'The cure is defined in the patient with reduced spleen and liver. Absence of fever for more than 15 days after treatment, weight gain, normalization of globulins and resolution of leukopenia and anemia.'}], 'secondaryOutcomes': [{'measure': 'Immune response of visceral leishmaniasis patients after proposed treatment', 'timeFrame': 'one year', 'description': 'Evaluation of the Immune response: peripheral blood mononuclear cells of patients are being obtained in ficoll-Hypaque gradient and stimulated in vitro with soluble antigen of L. chagasi to evaluate the production of cytokines (IFN-g, TNF-a. IL-10, TGF-b) before treatment, 15, 45, 180 and 360 days afterwards.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Visceral leishmaniasis', 'N-acetylcysteine', 'Antimony', 'Immune response'], 'conditions': ['Visceral Leishmaniasis', 'Immune Response', 'Treatment']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.', 'detailedDescription': 'In this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis N-acetylcysteine (NAC) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. Our hypothesis is that patients treated with NAC associated with pentavalent atimonial have a rapid changing of the immune responses, towards TH1, and clinical improvement when compared to patients who will use only the standard treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 2 to 50 years\n* Diagnosis of visceral leishmaniasis\n\nExclusion Criteria:\n\n* Other acute or chronic diseases\n* Use of immunosuppressive drugs\n* AIDS\n* History of allergy to NAC and/or pentavalent antimony'}, 'identificationModule': {'nctId': 'NCT01138956', 'acronym': 'VLNAC', 'briefTitle': 'Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitário Professor Edgard Santos'}, 'officialTitle': 'Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine', 'orgStudyIdInfo': {'id': 'VLNAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Pentavalent antimonial, 20mg/kg/day, 28 days', 'interventionNames': ['Drug: Pentavalent antimonial']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'description': 'N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days', 'armGroupLabels': ['Group 1']}, {'name': 'Pentavalent antimonial', 'type': 'DRUG', 'description': 'Pentavalent antimonial, 20mg/kg/day, 28 days, IV', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49060-100', 'city': 'Aracaju', 'state': 'Sergipe', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Roque P Almeida, MD, PhD', 'role': 'CONTACT', 'email': 'roquepacheco@uol.com.br', 'phone': '5579-21051806'}, {'name': 'Enaldo V Melo, MD', 'role': 'CONTACT', 'email': 'evm.estatistica@gmail.com', 'phone': '5579-21051700'}, {'name': 'Angela M Silva, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': -10.91111, 'lon': -37.07167}}], 'centralContacts': [{'name': 'Roque P Almeida, MD, PhD', 'role': 'CONTACT', 'email': 'roquepacheco@uol.com.br', 'phone': '5579-21051806'}, {'name': 'Enaldo V Melo, MD', 'role': 'CONTACT', 'email': 'evm.estatistica@gmail.com', 'phone': '5579-21051700'}], 'overallOfficials': [{'name': 'Roque P Almeida, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitário'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitário Professor Edgard Santos', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Roque Pacheco de Almeida', 'oldOrganization': 'Universidade Federal de Sergipe'}}}}