Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pregnancy Complications Parasitic

Intervention / Treatment
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* Drug: Efficacy of suphladoxine/pyrimethamine as IPTp
* Drug: Efficacy of suphladoxine/pyrimethamine as IPTp


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-IPTp efficacy<br>Efficacy of suphladoxine/pyrimethamine as IPTp | Drug: Efficacy of suphladoxine/pyrimethamine as IPTp<br>* 3 tablets (single dose)given twice during pregnancy one month apart after quickening<br>* Other names: Fansidar;Drug: Efficacy of suphladoxine/pyrimethamine as IPTp<br>* 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<br>* Other names: Fansidar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women | PCR uncorrected parasitological clearance by day 42 | 15 months | 
| 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 | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, pregnancy, prevention, treatment, molecular markers