Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria (OR1)

August 21, 2012 updated by: Malaria Consortium, UK

An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • borno State and Enugu state
      • Enugu,, borno State and Enugu state, Nigeria
        • Recruiting
        • Damboa Hospital Borno state and Park Lane hospital Enugu state
        • Contact:
        • Principal Investigator:
          • Elvis Shu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SP-IPTp efficacy
Efficacy of suphladoxine/pyrimethamine as IPTp
Drug: Efficacy of suphladoxine/pyrimethamine as IPTp
3 tablets (single dose)given twice during pregnancy one month apart after quickening
Other Names:
  • Fansidar
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
Other Names:
  • Fansidar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women
Time Frame: 15 months
PCR corrected Adequate parasitological clearance by day 42
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women
Time Frame: 15 months
PCR uncorrected parasitological clearance by day 42
15 months
To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women
Time Frame: 15 months
Prevalence of molecular markers of SP resistance at enrolment
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malaria Consortium, UK

Collaborators

London School of Hygiene and Tropical Medicine
Department for International Development, United Kingdom
University of Nigeria, Enugu Campus

Investigators

  • Study Chair: Daniel Chandramohan, PHD, London School of Hygeine and Tropical Medicine
  • Principal Investigator: Elvis N Shu, PHD, College of Medicine, University of Nigeria , Enugu Campus
  • Study Director: Ebenezer S Baba, MBBS, MPH, Malaria Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SuNMaP-OR1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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