Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT01837992
Status:
UNKNOWN
Last Update Posted:
2013-11-08
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Primaquine for P. Vivax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011319', 'term': 'Primaquine'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Numbers of Plasmodium vivax relapses per person-years of follow-', 'timeFrame': '12 months', 'description': 'Total number of microscopically diagnosed (including both symptomatic and asymptomatic infections), PCR-confirmed relapses with Plasmodium vivax in participants in each treatment arm over the 3-month follow-up period, expressed as number of relapses per person-years of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Safety and toxicity (1): Numbers with mild adverse events', 'timeFrame': '12 months', 'description': 'Numbers in each treatment arm experiencing any documented adverse event defined as "mild" (not severe enough to interfere with daily activities).'}, {'measure': 'Safety and toxicity (2) Numbers with moderate adverse events', 'timeFrame': '12 months', 'description': 'Numbers in each treatment arm experiencing any documented adverse event defined as "moderate" (severe enough to interfere with daily activities but not severe enough to warrant admission to hospital).'}, {'measure': 'Safety and toxicity (3) Numbers with severe adverse events', 'timeFrame': '12 months', 'description': 'Numbers in each treatment arm experiencing any documented adverse event defined as "severe" (severe to warrant admission to hospital or to be considered a risk for death or disability arising from the event).'}, {'measure': 'Safety and toxicity (4) Numbers with any adverse events', 'timeFrame': '12 months', 'description': 'Numbers in each treatment arm experiencing any documented event (defined as either mild, moderate or severe as above).'}, {'measure': 'Safety and toxicity (5) Numbers with assumed significant haemolysis', 'timeFrame': '12 months', 'description': 'Numbers in each treatment arm experiencing any of the following:\n\n1. Haemoglobinuria on dipstick examination\n2. Scleral icterus\n3. Haemoglobin concentration fall by more than 25% of baseline or absolute concentration \\<5g/dL'}, {'measure': 'Safety and toxicity (6) Numbers with significant methaemoglobinaemia', 'timeFrame': '12 months', 'description': 'Numbers in each treatment arm experiencing any of the following:\n\n1. Cyanosis (blue tongue, lips and peripheries)\n2. Measured methaemoglobin saturation (using Masimo Rad-57 plus oximeter) \\>15%\n3. Measured oxygen saturation \\<85%'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': 'The Melanesian states of the Western Pacific (Papua New Guinea, Solomon Islands and Vanuatu) represent a unique and especially prescient challenge to malaria control and elimination.\n\nWhile the use of bed nets and other vector control and case management measures have achieved major advances in overall malaria control, the P. vivax and P. ovale species account for an ever-increasing burden of clinical disease.\n\nThe lack of effective treatment of the hypnozoite stages of infection with these species result in ongoing relapses and a continuing reservoir of infection.\n\nThe only known drug effective for treatment of the hypnozoite stage is primaquine; however the safe and effective dose of this drug in malaria treatment is still unclear.\n\nA recent study evaluated the safety and efficacy of two primaquine dosing regimens (0.25mg/kg and 0.5mg/kg) in a population in New Ireland province, PNG. This study aims to replicate this methodology in Vanuatu and Solomon Islands, to provide a more complete picture of primaquine efficacy and safety in each of the three countries of this region.', 'detailedDescription': 'Study Aims\n\nPrimary To define and compare the efficacy of standard (0.25mg/kg/day for 14 days) and high-dose (0.5mg/kg/day for 14 days) primaquine in preventing early relapses from P. vivax in Solomon Islands and Vanuatu.\n\nSecondary To measure safety and toxicity of primaquine when administered as a standard or high-dose regimen in Melanesian adults and children in Solomon Islands and Vanuatu.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 12 months to 60 years\n2. Melanesian background and living in local area\n3. Microscopically (based on field microscopy) or RDT confirmed P.vivax regardless of parasite density. Mixed infections (P.falciparum-P.vivax and P.malariae-P.vivax) can be included.\n\nExclusion Criteria:\n\n1. Any signs of severe malaria (see WHO definitions) including: impaired consciousness, respiratory distress, severe anaemia (Hb\\<5), multiple seizures, frequent vomiting/ inability to swallow tablets, prostration, jaundice, hypotension, abnormal bleeding or hypoglycaemia.\n2. Clinical evidence of non-malarial illness (such as pneumonia or otitis media)\n3. Severe malnutrition (weight-for-age nutritional Z score \\[WAZ\\] \\<60th percentile)\n4. Permanent disability, which prevents or impedes study participation.\n5. Treatment with primaquine in the previous 14 days\n6. Residence or planned travel outside the study area during the follow-up period (precluding supervised treatment and follow-up procedures)\n7. Known or suspected pregnancy\n8. Currently breastfeeding\n9. A positive rapid test for G6PD deficiency (Binax or Carestart RDT)\n\nFollowing later PCR-based confirmation of malaria speciation, there may be some post-hoc exclusion of subjects in whom it is thought the initial field-based microscopic diagnosis may have been incorrect.'}, 'identificationModule': {'nctId': 'NCT01837992', 'briefTitle': 'Safety and Efficacy of Primaquine for P. Vivax', 'organization': {'class': 'OTHER', 'fullName': 'Menzies School of Health Research'}, 'officialTitle': 'Evaluation of Safety and Efficacy of Two Primaquine Dosing Regimens for the Radical Treatment of Plasmodium Vivax Malaria in Vanuatu and Solomon Islands', 'orgStudyIdInfo': {'id': 'VanSI_2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose', 'description': 'Participants will receive a standard 3-day treatment course of artemether-lumefantrine at the standard age-based dosage, and will be administered the standard recommended primaquine dose of 0.25mg/kg for 14 consecutive days.', 'interventionNames': ['Drug: Primaquine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose', 'description': 'Participants will receive a standard 3-day treatment course of artemether-lumefantrine at the standard age-based dosage, and will be administered a primaquine dose of 0.5mg/kg/day for 14 consecutive days.', 'interventionNames': ['Drug: Primaquine']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Participants will receive a standard 3-day treatment course of artemether-lumefantrine at the standard age-based dosage, but will not receive primaquine until the time of confirmed recurrent parasitaemia or completion of 3 months follow up.', 'interventionNames': ['Drug: delayed primaquine']}], 'interventions': [{'name': 'Primaquine', 'type': 'DRUG', 'armGroupLabels': ['High dose', 'Standard dose']}, {'name': 'delayed primaquine', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Honiara', 'state': 'Guadalcanal Province', 'country': 'Solomon Islands', 'contacts': [{'name': 'Lyndes Wini', 'role': 'CONTACT'}, {'name': 'Albino Bobogare', 'role': 'CONTACT'}], 'facility': 'Tetere Hospital, Guadalcanal Province'}, {'city': 'Auki', 'state': 'Malaita Province', 'country': 'Solomon Islands', 'contacts': [{'name': 'Albino Bobogare', 'role': 'CONTACT'}, {'name': 'Lyndes Wini', 'role': 'CONTACT'}], 'facility': 'Aoki Hospital, Malaita Province', 'geoPoint': {'lat': -8.76778, 'lon': 160.69778}}, {'city': 'Luganville', 'state': 'Sanma', 'country': 'Vanuatu', 'contacts': [{'name': 'George Taleo', 'role': 'CONTACT'}, {'name': 'Edward Tambisari', 'role': 'CONTACT'}], 'facility': 'Northern Provincial Hospital, Nambauk Aid Post, V.F.H.A Dispensary and Fanafo Dispensary', 'geoPoint': {'lat': -15.51989, 'lon': 167.16235}}, {'city': 'Port Vila', 'state': 'Shefa Province', 'country': 'Vanuatu', 'contacts': [{'name': 'George Taleo', 'role': 'CONTACT'}, {'name': 'Edward Tambisari, MD', 'role': 'CONTACT'}], 'facility': 'Toroa Dispensary, NTM Health Centre and Vila Central Hospital', 'geoPoint': {'lat': -17.73648, 'lon': 168.31366}}], 'centralContacts': [{'name': 'Ivo Mueller, PhD', 'role': 'CONTACT', 'email': 'mueller@wehi.edu.au', 'phone': '+61 3 9345 2555'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menzies School of Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Walter and Eliza Hall Institute of Medical Research', 'class': 'OTHER'}, {'name': 'Ministry of Health, Vanuatu', 'class': 'OTHER_GOV'}, {'name': 'Ministry of Health, Solomon Islands', 'class': 'OTHER_GOV'}, {'name': 'World Health Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}