Assessment of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi

NCT01120145 | Completed

• 1 other identifier: CDC-CGH-5756
• Study Type: observational
• Target: 1,410
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and effectiveness of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing malaria-associated morbidity in pregnant women in Malawi.

Conditions

Malaria in Pregnancy

Keywords

Malaria; Pregnancy; Sulphadoxine-pyrimethamine

Outcome Measures

Primary Outcomes (3)

• Therapeutic efficacy study: Development of fever or symptoms of severe malaria (defined by WHO) and parasitemia at any time after the first dose of SP during the 42 day follow up period

  42 days

• Birth outcomes study: Evidence of malaria infection based on placental histology at the time of delivery

  At time of birth

• Characterizing molecular markers of SP resistance: Prevalence of molecular markers of sulphadoxine-pyrimethamine resistance at the time of health facility visit

  Day 1

Study Arms (3)

Therapeutic efficacy study

Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation will be enrolled into the study and followed weekly for 42 days after the receipt of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy to assess the clearance of parasitemia.

Birth outcomes study

Women presenting for delivery will be enrolled and assessed for a history of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy and evidence of malaria infection by placental histology, maternal peripheral parasitemia, maternal anemia and infant cord blood parasitemia.

Characterizing molecular markers of SP resistance

Parasitemic outpatients attending the health facility will be tested for parasite molecular markers of sulphadoxine-pyrimethamine resistance.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Therapeutic efficacy study: Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation Birth outcomes study: Pregnant women presenting for delivery Characterizing molecular markers of SP resistance study: Parasitemic outpatients

You may qualify if:

• weeks gestation based on last menstrual period (LMP) or quickening
• Axillary temperature \<37.5 degrees Celsius
• Informed consent

You may not qualify if:

• History of hypersensitivity reaction to SP or components of SP
• Axillary temperature ≥37.5 degrees C
• History of receipt of antimalarials in the past month
• Known HIV infection
• Birth outcomes study:
• Singleton pregnancy
• SP IPTp history available
• Informed consent
• Blood transfusion after the 16th gestational week
• Receipt of antimalarials other than SP for IPTp after 16th gestational week
• Known HIV infection
• Characterizing molecular markers of SP resistance:
• Outpatient attending selected health facility
• Informed consent
• None

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Machinga District Hospital

Liwonde, Machinga District, Malawi

Location

Related Publications (1)

• Gutman J, Mwandama D, Wiegand RE, Abdallah J, Iriemenam NC, Shi YP, Mathanga DP, Skarbinski J. In vivo efficacy of sulphadoxine-pyrimethamine for the treatment of asymptomatic parasitaemia in pregnant women in Machinga District, Malawi. Malar J. 2015 May 13;14:197. doi: 10.1186/s12936-015-0710-7.

  PMID: 25962439 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood spots will be collected from parasitemic patients to look at malaria prasite molecular markers of resistance to sulphadoxine-pyrimethamine.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Jacek Skarbinski, MD

  Malaria Branch, Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Don Mathanga, MD, PhD

  Kamuzu University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: FED

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 10, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

MA (1)