Sulphadoxine-Pyrimethamine for Intermittent Preventive Tr... | NCT01184911

Studies
Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

NCT01184911

Sponsor

University of California, San Francisco

Status

Withdrawn

Last Update Posted

Mar 5, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Intermittent Preventive Treatment
Placental Malaria

Interventions

Sulfadoxine-pyrimethamine

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Research plan changed; no longer conducting clinical trial.

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 17, 2010

First Posted Date

Aug 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2015

Last Update Posted Date

Mar 5, 2015Estimated

Name	Class
Centers for Disease Control and Prevention	FED
Uganda Malaria Surveillance Project	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SP	Experimental	Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria	Drug: Sulfadoxine-pyrimethamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sulfadoxine-pyrimethamine	Drug	Sulfadoxine-pyrimethamine tablets, once	SP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parasite clearance	Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP	42 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Infectious Disease Research Center		Tororo	Tororo		Uganda

Label	URL
UMSP website	View source

Condition Browse Module

MeSH Terms

ID	Term
D008288	Malaria

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Browse Leaves

Not provided

Browse Branches

Not provided