Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-06 @ 4:00 PM
Study NCT ID:
NCT01636895
Status:
UNKNOWN
Last Update Posted:
2012-08-22
First Post:
2012-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015597', 'term': 'Pregnancy Complications, Parasitic'}, {'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011251', 'term': 'Pregnancy Complications, Infectious'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011739', 'term': 'Pyrimethamine'}, {'id': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}], 'ancestors': [{'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2012-07-05', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women', 'timeFrame': '15 months', 'description': 'PCR corrected Adequate parasitological clearance by day 42'}], 'secondaryOutcomes': [{'measure': 'To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women', 'timeFrame': '15 months', 'description': 'PCR uncorrected parasitological clearance by day 42'}, {'measure': 'To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women', 'timeFrame': '15 months', 'description': 'Prevalence of molecular markers of SP resistance at enrolment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['malaria', 'pregnancy', 'prevention', 'treatment', 'molecular markers'], 'conditions': ['Pregnancy Complications Parasitic']}, 'descriptionModule': {'briefSummary': 'The study has two components: component A is a cohort study to determine the in vivo efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component B is a cross sectional study of women delivering at the study hospitals to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance. Results of component A and B studies will be used to model the relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.', 'detailedDescription': 'Study sites will include different levels of transmission and social factors affecting ANC attendance Damboa hospital in Borno state has a catchment area with pop of 231,573 with a semi arid climate and where malaria is mesoendemic. The expected number of patients is 15-25 per week for new bookings Park Lane hospital serves a semiurban population. Malaria transmission is holoendemic and stable. 1400 women attend ANC services per month Women will receive SP-IPTp according to National guidelines and will be followed for 42 days to assess the therapeutic efficacy in parasitaemic women and to assess the ability to remain parasite free. PCR will be used to determine reinfection from recrudescence'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age 16-30 weeks\n* Axillary temperature ,37.5 Degrees\n* informed consent\n\nExclusion Criteria:\n\n* gravida \\> 2\n* previous inclusion in this study\n* history of hypersensitivity to SP or components of SP\n* Use of IPTp with SP during this pregnancy\n* history of taking other antimalarials in the past month\n* Known HIV infection'}, 'identificationModule': {'nctId': 'NCT01636895', 'acronym': 'OR1', 'briefTitle': 'Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria', 'organization': {'class': 'NETWORK', 'fullName': 'Malaria Consortium, UK'}, 'officialTitle': 'An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria', 'orgStudyIdInfo': {'id': 'SuNMaP-OR1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SP-IPTp efficacy', 'description': 'Efficacy of suphladoxine/pyrimethamine as IPTp', 'interventionNames': ['Drug: Efficacy of suphladoxine/pyrimethamine as IPTp']}], 'interventions': [{'name': 'Efficacy of suphladoxine/pyrimethamine as IPTp', 'type': 'DRUG', 'otherNames': ['Fansidar'], 'description': '3 tablets (single dose)given twice during pregnancy one month apart after quickening', 'armGroupLabels': ['SP-IPTp efficacy']}, {'name': 'Efficacy of suphladoxine/pyrimethamine as IPTp', 'type': 'DRUG', 'otherNames': ['Fansidar'], 'description': '2 courses of 3 tablets of 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine)administered (at least 1 month apart) as DOTs to pregnant mother after quickening', 'armGroupLabels': ['SP-IPTp efficacy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Enugu', 'state': 'Borno State and Enugu State', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Elvis N Shu', 'role': 'CONTACT', 'email': 'shuneba@gmail.com', 'phone': 'Cell: + 234 803 317 0257'}, {'name': 'Elvis Shu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Damboa Hospital Borno state and Park Lane hospital Enugu state', 'geoPoint': {'lat': 6.44132, 'lon': 7.49883}}], 'centralContacts': [{'name': 'Dr Ebenezer Baba', 'role': 'CONTACT'}, {'name': 'Dr Elvis Shu', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Daniel Chandramohan, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'London School of hygeine and tropical medicine'}, {'name': 'Elvis N Shu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Medicine, University of Nigeria , Enugu Campus'}, {'name': 'Ebenezer S Baba, MBBS, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Malaria Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malaria Consortium, UK', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Department for International Development, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'University of Nigeria, Enugu Campus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}