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Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda (SP IPTp)

This study has been withdrawn prior to enrollment.
(Research plan changed; no longer conducting clinical trial.)
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Uganda Malaria Surveillance Project
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01184911
First received: August 17, 2010
Last updated: October 13, 2010
Last verified: July 2010
History of Changes
  Purpose

The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.


Condition Intervention Phase
Intermittent Preventive Treatment
Placental Malaria
 Drug: Sulfadoxine-pyrimethamine
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Parasite clearance [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP


Estimated Enrollment: 151
Study Start Date: October 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SP
Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria
 Drug: Sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine tablets, once
Other Name: Kamsidar, Fansidar

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16-26 weeks gestation based on LMP or ultrasound or fundal height
  • Axillary temperature <37.5 degrees C
  • Informed consent
  • HIV status known and negative
  • Blood smear positive for falciparum malaria

Exclusion Criteria:

  • History of hypersensitivity reaction to SP or components of SP
  • Axillary temperature ≥37.5 degrees C
  • History of receipt of antimalarials or antibiotics with antimalarial activity* in the past month
  • Residence > 30 km from the ANC clinic or unwillingness to return for follow-up visits

  • Hemoglobin level < 5 gm/dL

    • These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184911

Locations
Uganda
Infectious Disease Research Center
Tororo, Uganda
Sponsors and Collaborators
University of California, San Francisco
Centers for Disease Control and Prevention
Uganda Malaria Surveillance Project
Investigators
Principal Investigator: Veronica Ades, MD, MPH University of California, San Francisco
Principal Investigator: Scott Filler, MD, DTM&H Centers for Disease Control and Prevention
Principal Investigator: Moses Kamya, MBChB, MMed, MPH, PhD Uganda Malaria Surveillance Project
  More Information

Additional Information:
UMSP website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Grant Dorsey, University of California San Francisco
ClinicalTrials.gov Identifier: NCT01184911     History of Changes
Other Study ID Numbers: CDC5972
Study First Received: August 17, 2010
Last Updated: October 13, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government
Uganda: National Drug Authority
Uganda: National Council for Science and Technology
Uganda: Research Ethics Committee

Keywords provided by University of California, San Francisco:
Malaria
Pregnancy

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on June 17, 2013