Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

NCT01636895 | Unknown Phase 4 DMC

• 1 other identifier: SuNMaP-OR1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Complications Parasitic

Keywords

malaria; pregnancy; prevention; treatment; molecular markers

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women

  PCR corrected Adequate parasitological clearance by day 42

  15 months

Secondary Outcomes (2)

• To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women

  15 months

• To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women

  15 months

Study Arms (1)

SP-IPTp efficacy

EXPERIMENTAL

Efficacy of suphladoxine/pyrimethamine as IPTp

Drug: Efficacy of suphladoxine/pyrimethamine as IPTp

Interventions

Efficacy of suphladoxine/pyrimethamine as IPTp DRUG

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

Also known as: Fansidar

SP-IPTp efficacy

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• gravida \> 2
• 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

Sponsors & Collaborators

• Malaria Consortium, UK: lead
• Department for International Development, United Kingdom: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• University of Nigeria, Enugu Campus: collaborator

Study Sites (1)

Damboa Hospital Borno state and Park Lane hospital Enugu state

Enugu, Borno State and Enugu State, Nigeria

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications, Parasitic; Malaria

Interventions

Pyrimethamine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections; Pregnancy Complications, Infectious; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Protozoan Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Daniel Chandramohan, PHD

  London School of hygeine and tropical medicine

  STUDY CHAIR

• Elvis N Shu, PHD

  College of Medicine, University of Nigeria , Enugu Campus

  PRINCIPAL INVESTIGATOR

• Ebenezer S Baba, MBBS, MPH

  Malaria Consortium

  STUDY DIRECTOR

Central Study Contacts

Dr Ebenezer Baba

CONTACT

Dr Elvis Shu

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: August 22, 2012

Record last verified: 2012-08

Locations

NG (1)