Study Stopped
Research plan changed; no longer conducting clinical trial.
Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
SP IPTp
Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2010
CompletedFirst Posted
Study publicly available on registry
August 19, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 5, 2015
March 1, 2015
11 months
August 17, 2010
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parasite clearance
Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP
42 days
Study Arms (1)
SP
EXPERIMENTALAsymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria
Interventions
Sulfadoxine-pyrimethamine tablets, once
Eligibility Criteria
You may qualify if:
- 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
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Infectious Disease Research Center
Tororo, Tororo, Uganda
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 17, 2010
First Posted
August 19, 2010
Study Start
October 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
March 5, 2015
Record last verified: 2015-03