Efficacy of Combination Therapy for Prevention of Effects... | NCT00164255

Studies
Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy

NCT00164255

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Sep 11, 2012Estimated

Enrollment

1,614Actual

Phase

Phase 4

Conditions

Malaria

Interventions

sulfadoxine/pyrimethamine
sulfadoxine/pyrimethamine plus artesunate

Countries

Tanzania

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

ID	Type	Description	Link
UR3/CCU018969-01

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

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

Sep 10, 2012

Last Update Posted Date

Sep 11, 2012Estimated

Name	Class
Ifakara Health Research and Development Centre	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

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

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

1,614Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
placental parasitemia
reported or noted adverse reactions

Secondary Outcomes

Measure	Description	Time Frame
parasitemia at delivery (maternal peripheral, placental and cord)
maternal illness
birth weight

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women 15 years of age or older
First or second pregnancy between 16 and 36 weeks gestation

Exclusion Criteria:

Pregnancy prior to 16 weeks or after 36 weeks gestation
Third or later pregnancy;
Report previous allergic reactions to SP, AS, or unknown antimalarials;
If the distance to their home is too great or too inaccessible for follow-up;
Child's father refuses the woman's participation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

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
John MacArthur, MD, MPH	Centers for Disease Control and Prevention	Principal Investigator
Salim Abdulla, MD, PhD	Ifakara Health Research and Development Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kibaoni Health Centre		Ifakara	Kilombero District		Tanzania
St Francis Designated District Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39324693	Derived	Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

ID	Term
D008288	Malaria
D001724	Birth Weight

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

ID	Term
C001205	fanasil, pyrimethamine drug combination
D013413	Sulfadoxine
D011739	Pyrimethamine
D000077332	Artesunate

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Name	Type	Description	Arm Group Labels	Other Names
sulfadoxine/pyrimethamine	Drug
sulfadoxine/pyrimethamine plus artesunate	Drug