Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-03 @ 8:24 AM
Study NCT ID:
NCT06720259
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014257', 'term': 'Trichuriasis'}, {'id': 'D006725', 'term': 'Hookworm Infections'}], 'ancestors': [{'id': 'D017189', 'term': 'Enoplida Infections'}, {'id': 'D017188', 'term': 'Adenophorea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017206', 'term': 'Strongylida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C037225', 'term': 'oxantel pamoate'}, {'id': 'D008463', 'term': 'Mebendazole'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura', 'timeFrame': '14-21 days after treatment', 'description': 'CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.'}], 'secondaryOutcomes': [{'measure': 'Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura', 'timeFrame': '14-21 days after treatment', 'description': 'Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.'}, {'measure': 'Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura', 'timeFrame': '14-21 days after treatment', 'description': 'CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.'}, {'measure': 'Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura', 'timeFrame': '14-21 days after treatment', 'description': 'CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.'}, {'measure': 'Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants', 'timeFrame': '14-21 days after treatment', 'description': 'CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.'}, {'measure': 'Number of adverse events (AE) to assess safety and tolerability of oxantel pamoate administered as a single dose or as multiple doses, and compared with mebendazole', 'timeFrame': '3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment', 'description': 'Participants will be monitored at the site for 3 hours following treatment for any acute AEs. Participants will be interviewed 3 hours after treatment, as well as 24 hours after every dose received, as well as 14-21days after the last treatment dose about the occurrence of AEs.\n\nAEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trichuris Trichiura; Infection', 'Hookworm Infection', 'Ascaris Lumbricoides Infection']}, 'descriptionModule': {'briefSummary': 'This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 2 and 12 years.\n* Written informed consent signed by parents/caregivers (signature or thumbprint) and, for children aged 6-12 years, written assent from the child.\n* Agree to comply with study procedures, including provision of two stool samples at the baseline and at follow-up assessment 14-21 days after treatment, respectively.\n* At least two out of four Kato-Katz thick smears positive for T. trichiura at baseline.\n* Willing to be examined by a study physician prior to treatment.\n\nExclusion Criteria:\n\n* Presence or signs of major systemic illness or abnormal physical findings at screening, e.g. severe anaemia (Hb level \\<80 g/L according to WHO) upon initial clinical assessment.\n* Known allergy to study medication (i.e. oxantel pamoate, mebendazole or any of the excipients).\n* Use of anthelminthic drugs within 4 weeks before or during study period.\n* Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.\n* Actively participating in other clinical trials during the study.\n* Pregnancy (female participants that report to have reached menarche'}, 'identificationModule': {'nctId': 'NCT06720259', 'acronym': 'OXA-TRI', 'briefTitle': 'Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Tropical & Public Health Institute'}, 'officialTitle': 'A Randomised, Single-Blinded Phase II Trial to Assess the Efficacy, Safety and Acceptability of Oxantel Pamoate in Comparison to Mebendazole for Trichuris Trichiura Infections in Children Aged 2-12 Years', 'orgStudyIdInfo': {'id': 'OXA-TRI_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxantel Single Dose', 'description': 'Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0', 'interventionNames': ['Drug: Oxantel Pamoate']}, {'type': 'EXPERIMENTAL', 'label': 'Oxantel Multiple Dose', 'description': 'Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2', 'interventionNames': ['Drug: Oxantel Pamoate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mebendazole Single Dose', 'description': 'Mebendazole (500mg), orally administered on day 0', 'interventionNames': ['Drug: Mebendazole']}], 'interventions': [{'name': 'Oxantel Pamoate', 'type': 'DRUG', 'description': 'Tablets containing 250 mg oxantel pamoate', 'armGroupLabels': ['Oxantel Multiple Dose', 'Oxantel Single Dose']}, {'name': 'Mebendazole', 'type': 'DRUG', 'description': 'Tablets containing 500 mg mebendazole', 'armGroupLabels': ['Mebendazole Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chake Chake', 'country': 'Tanzania', 'facility': 'Public Health Laboratory Ivo de Carneri', 'geoPoint': {'lat': -5.24586, 'lon': 39.76659}}], 'overallOfficials': [{'name': 'Jennifer Keiser, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Swiss Tropical & Public Health Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Keiser', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Laboratory Ivo de Carneri', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Jennifer Keiser', 'investigatorAffiliation': 'Swiss Tropical & Public Health Institute'}}}}