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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Malaria Consortium, UK.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Department for International Development, United Kingdom
London School of Hygiene and Tropical Medicine
University of Nigeria, Enugu Campus
Information provided by (Responsible Party):
Malaria Consortium, UK
ClinicalTrials.gov Identifier:
NCT01636895
First received: July 5, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Pregnancy Complications Parasitic
Drug: Efficacy of suphladoxine/pyrimethamine as IPTp
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria

Resource links provided by NLM:


Further study details as provided by Malaria Consortium, UK:

Primary Outcome Measures:
  • To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    PCR corrected Adequate parasitological clearance by day 42


Secondary Outcome Measures:
  • To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    PCR uncorrected parasitological clearance by day 42

  • To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Prevalence of molecular markers of SP resistance at enrolment


Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Fansidar

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

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636895

Contacts
Contact: Dr Ebenezer Baba
Contact: Dr Elvis Shu

Locations
Nigeria
Damboa Hospital Borno state and Park Lane hospital Enugu state Recruiting
Enugu,, borno State and Enugu state, Nigeria
Contact: Elvis N Shu    Cell: + 234 803 317 0257    shuneba@gmail.com   
Principal Investigator: Elvis Shu         
Sponsors and Collaborators
Malaria Consortium, UK
Department for International Development, United Kingdom
London School of Hygiene and Tropical Medicine
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
  More Information

No publications provided

Responsible Party: Malaria Consortium, UK
ClinicalTrials.gov Identifier: NCT01636895     History of Changes
Other Study ID Numbers: SuNMaP-OR1
Study First Received: July 5, 2012
Last Updated: August 21, 2012
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by Malaria Consortium, UK:
malaria
pregnancy
prevention
treatment
molecular markers

Additional relevant MeSH terms:
Pregnancy Complications
Pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014