Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria (OR1)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy Complications Parasitic |
Drug: Efficacy of suphladoxine/pyrimethamine as IPTp |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria |
- To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women [ Time Frame: 15 months ] [ Designated as safety issue: No ]PCR corrected Adequate parasitological clearance by day 42
- To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]PCR uncorrected parasitological clearance by day 42
- To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women [ Time Frame: 15 months ] [ Designated as safety issue: No ]Prevalence of molecular markers of SP resistance at enrolment
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SP-IPTp efficacy
Efficacy of suphladoxine/pyrimethamine as IPTp
|
Drug: Efficacy of suphladoxine/pyrimethamine as IPTp
3 tablets (single dose)given twice during pregnancy one month apart after quickening
Other Name: Fansidar
Drug: Efficacy of suphladoxine/pyrimethamine as IPTp
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
Other Name: Fansidar
|
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
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Dr Ebenezer Baba | ||
| Contact: Dr Elvis Shu |
| Nigeria | |
| Damboa Hospital Borno state and Park Lane hospital Enugu state | Recruiting |
| Enugu,, borno State and Enugu state, Nigeria | |
| Contact: Elvis N Shu Cell: + 234 803 317 0257 shuneba@gmail.com | |
| Principal Investigator: Elvis Shu | |
| Study Chair: | Daniel Chandramohan, PHD | London School of hygeine and tropical medicine |
| Principal Investigator: | Elvis N Shu, PHD | College of Medicine, University of Nigeria , Enugu Campus |
| Study Director: | Ebenezer S Baba, MBBS, MPH | Malaria Consortium |
More Information
No publications provided
| Responsible Party: | Malaria Consortium, UK |
| ClinicalTrials.gov Identifier: | NCT01636895 History of Changes |
| Other Study ID Numbers: | SuNMaP-OR1 |
| Study First Received: | July 5, 2012 |
| Last Updated: | August 21, 2012 |
| Health Authority: | Nigeria: The National Agency for Food and Drug Administration and Control |
Keywords provided by Malaria Consortium, UK:
|
malaria pregnancy prevention treatment molecular markers |
Additional relevant MeSH terms:
|
Pregnancy Complications Pyrimethamine Sulfadoxine-pyrimethamine Antimalarials Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013