Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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This study has been withdrawn prior to enrollment.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.)
Centers for Disease Control and Prevention
Uganda Malaria Surveillance Project
Information provided by:
University of California, San Francisco Identifier:
First received: August 17, 2010
Last updated: March 3, 2015
Last verified: March 2015
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: 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:

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

Primary Outcome Measures:
  • Parasite clearance [ Time Frame: 42 days ]
    Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP

Enrollment: 0
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01184911

Infectious Disease Research Center
Tororo, Uganda
Sponsors and Collaborators
University of California, San Francisco
Centers for Disease Control and Prevention
Uganda Malaria Surveillance Project
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

Responsible Party: Grant Dorsey, University of California San Francisco Identifier: NCT01184911     History of Changes
Other Study ID Numbers: CDC5972
Study First Received: August 17, 2010
Last Updated: March 3, 2015

Keywords provided by University of California, San Francisco:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents processed this record on May 25, 2017