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Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria (OR1)

Primary Purpose

Pregnancy Complications Parasitic

Status

Unknown status

Phase

Phase 4

Locations

Nigeria

Study Type

Interventional

Intervention

Efficacy of suphladoxine/pyrimethamine as IPTp

About this trial

This is an interventional prevention trial for Pregnancy Complications Parasitic focused on measuring malaria, pregnancy, prevention, treatment, molecular markers

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

gestational age 16-30 weeks
Axillary temperature ,37.5 Degrees
informed consent

Exclusion Criteria:

gravida > 2
previous inclusion in this study
history of hypersensitivity to SP or components of SP
Use of IPTp with SP during this pregnancy
history of taking other antimalarials in the past month
Known HIV infection

Sites / Locations

Damboa Hospital Borno state and Park Lane hospital Enugu stateRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SP-IPTp efficacy

Arm Description

Efficacy of suphladoxine/pyrimethamine as IPTp

Outcomes

Primary Outcome Measures

To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women

PCR corrected Adequate parasitological clearance by day 42

Secondary Outcome Measures

To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women

PCR uncorrected parasitological clearance by day 42

To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women

Prevalence of molecular markers of SP resistance at enrolment

Full Information

NCT ID

NCT01636895

First Posted

July 5, 2012

Last Updated

August 21, 2012

Sponsor

Malaria Consortium, UK

Collaborators

Department for International Development, United Kingdom, London School of Hygiene and Tropical Medicine, University of Nigeria, Enugu Campus

1. Study Identification

Unique Protocol Identification Number

NCT01636895

Brief Title

Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

Acronym

OR1

Official Title

An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Malaria Consortium, UK

Collaborators

Department for International Development, United Kingdom, London School of Hygiene and Tropical Medicine, University of Nigeria, Enugu Campus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study has two components: component A is a cohort study to determine the in vivo efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component B is a cross sectional study of women delivering at the study hospitals to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance. Results of component A and B studies will be used to model the relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.

Detailed Description

Study sites will include different levels of transmission and social factors affecting ANC attendance Damboa hospital in Borno state has a catchment area with pop of 231,573 with a semi arid climate and where malaria is mesoendemic. The expected number of patients is 15-25 per week for new bookings Park Lane hospital serves a semiurban population. Malaria transmission is holoendemic and stable. 1400 women attend ANC services per month Women will receive SP-IPTp according to National guidelines and will be followed for 42 days to assess the therapeutic efficacy in parasitaemic women and to assess the ability to remain parasite free. PCR will be used to determine reinfection from recrudescence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy Complications Parasitic

Keywords

malaria, pregnancy, prevention, treatment, molecular markers

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SP-IPTp efficacy

Arm Type

Experimental

Arm Description

Efficacy of suphladoxine/pyrimethamine as IPTp

Intervention Type

Drug

Intervention Name(s)

Efficacy of suphladoxine/pyrimethamine as IPTp

Other Intervention Name(s)

Fansidar

Intervention Description

3 tablets (single dose)given twice during pregnancy one month apart after quickening

Intervention Type

Drug

Intervention Name(s)

Efficacy of suphladoxine/pyrimethamine as IPTp

Other Intervention Name(s)

Fansidar

Intervention Description

2 courses of 3 tablets of 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine)administered (at least 1 month apart) as DOTs to pregnant mother after quickening

Primary Outcome Measure Information:

Title

To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women

Description

PCR corrected Adequate parasitological clearance by day 42

Time Frame

15 months

Secondary Outcome Measure Information:

Title

To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women

Description

PCR uncorrected parasitological clearance by day 42

Time Frame

15 months

Title

To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women

Description

Prevalence of molecular markers of SP resistance at enrolment

Time Frame

15 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: gestational age 16-30 weeks Axillary temperature ,37.5 Degrees informed consent Exclusion Criteria: gravida > 2 previous inclusion in this study history of hypersensitivity to SP or components of SP Use of IPTp with SP during this pregnancy history of taking other antimalarials in the past month Known HIV infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr Ebenezer Baba

First Name & Middle Initial & Last Name or Official Title & Degree

Dr Elvis Shu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Chandramohan, PHD

Organizational Affiliation

London School of hygeine and tropical medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Elvis N Shu, PHD

Organizational Affiliation

College of Medicine, University of Nigeria , Enugu Campus

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ebenezer S Baba, MBBS, MPH

Organizational Affiliation

Malaria Consortium

Official's Role

Study Director

Facility Information:

Facility Name

Damboa Hospital Borno state and Park Lane hospital Enugu state

City

Enugu,

State/Province

borno State and Enugu state

Country

Nigeria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elvis N Shu

Phone

Cell: + 234 803 317 0257

shuneba@gmail.com

First Name & Middle Initial & Last Name & Degree

Elvis Shu

12. IPD Sharing Statement

Learn more about this trial

Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

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