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Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

NCT ID: NCT01636895

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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

Conditions

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Pregnancy Complications Parasitic

Keywords

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malaria pregnancy prevention treatment molecular markers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SP-IPTp efficacy

Efficacy of suphladoxine/pyrimethamine as IPTp

Group Type EXPERIMENTAL

Efficacy of suphladoxine/pyrimethamine as IPTp

Intervention Type DRUG

3 tablets (single dose)given twice during pregnancy one month apart after quickening

Efficacy of suphladoxine/pyrimethamine as IPTp

Intervention Type DRUG

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

Interventions

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Efficacy of suphladoxine/pyrimethamine as IPTp

3 tablets (single dose)given twice during pregnancy one month apart after quickening

Intervention Type DRUG

Efficacy of suphladoxine/pyrimethamine as IPTp

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

Intervention Type DRUG

Other Intervention Names

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Fansidar Fansidar

Eligibility Criteria

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Inclusion Criteria

* gestational age 16-30 weeks
* Axillary temperature ,37.5 Degrees
* informed consent

Exclusion Criteria

* gravida \> 2
* previous inclusion in this study
* history of hypersensitivity to SP or components of SP
* Use of IPTp with SP during this pregnancy
* history of taking other antimalarials in the past month
* Known HIV infection
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

University of Nigeria, Enugu Campus

OTHER

Sponsor Role collaborator

Malaria Consortium, UK

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Chandramohan, PHD

Role: STUDY_CHAIR

London School of hygeine and tropical medicine

Elvis N Shu, PHD

Role: PRINCIPAL_INVESTIGATOR

College of Medicine, University of Nigeria , Enugu Campus

Ebenezer S Baba, MBBS, MPH

Role: STUDY_DIRECTOR

Malaria Consortium

Locations

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Damboa Hospital Borno state and Park Lane hospital Enugu state

Enugu, Borno State and Enugu State, Nigeria

Site Status RECRUITING

Countries

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Nigeria

Central Contacts

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Dr Ebenezer Baba

Role: CONTACT

Dr Elvis Shu

Role: CONTACT

Facility Contacts

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Elvis N Shu

Role: primary

Other Identifiers

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SuNMaP-OR1

Identifier Type: -

Identifier Source: org_study_id