Pregnancy Complications ParasiticPhase 4OR1NCT01636895
Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria
A Phase 4 study testing Efficacy of suphladoxine/pyrimethamine as IPTp in people with Pregnancy Complications Parasitic, run by Malaria Consortium, UK at 1 site in Nigeria.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications Parasitic
- What is being tested?
- Efficacy of suphladoxine/pyrimethamine as IPTp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNigeria
- Study dates
- Jan 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- gestational age 16-30 weeks
- Axillary temperature ,37.5 Degrees
- informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Dr Ebenezer Baba contact
Dr Elvis Shu contact
Nigeria1 site, 1 recruiting
- Recruiting
Damboa Hospital Borno state and Park Lane hospital Enugu state
Enugu, Borno State and Enugu State
Elvis N Shu, Cell: + 234 803 317 0257, shuneba@gmail.com
Elvis Shu
About this study
Official title: An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria
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.
Read the 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
- Conditions
- Pregnancy Complications Parasitic
- Being tested
- Efficacy of suphladoxine/pyrimethamine as IPTp
- Keywords
- malaria, pregnancy, prevention, treatment, molecular markers
- Medical subject headings
- Pregnancy Complications, Parasitic, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of suphladoxine/pyrimethamine as IPTpDrug
Also called Fansidar
3 tablets (single dose)given twice during pregnancy one month apart after quickening
Efficacy of suphladoxine/pyrimethamine as IPTpDrug
Also called Fansidar
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
| Study group | Role | What they receive |
|---|---|---|
| SP-IPTp efficacy | Experimental | Efficacy of suphladoxine/pyrimethamine as IPTp Receives: Drug: Efficacy of suphladoxine/pyrimethamine as IPTp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Secondary outcomes (2)
To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women
PCR uncorrected parasitological clearance by day 42
Measured: 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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionNov 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Complications ParasiticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malaria Consortium, UK
- Sponsor type
- Research network
- Collaborators
- Department for International Development, United Kingdom, London School of Hygiene and Tropical Medicine, University of Nigeria, Enugu Campus
- Responsible party
- Sponsor
- Investigators
- Daniel Chandramohan, PHD, Study chair, London School of hygeine and tropical medicineElvis N Shu, PHD, Principal investigator, College of Medicine, University of Nigeria , Enugu CampusEbenezer S Baba, MBBS, MPH, Study director, Malaria Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636895
- Sponsor's protocol ID
- SuNMaP-OR1
- Acronym
- OR1
- Status last verified
- Aug 2012
- First submitted
- 5 Jul 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria
- ClinicalTrials.gov ID
- NCT01636895
- Acronym / sponsor ID
- OR1 / SuNMaP-OR1
- Conditions
- Pregnancy Complications Parasitic
- Keywords
- malaria, pregnancy, prevention, treatment, molecular markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Malaria Consortium, UKResearch network
- Collaborators
- Department for International Development, United Kingdom, London School of Hygiene and Tropical Medicine, University of Nigeria, Enugu Campus
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SP-IPTp efficacy | Experimental | Drug: Efficacy of suphladoxine/pyrimethamine as IPTpEfficacy of suphladoxine/pyrimethamine as IPTp |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- gestational age 16-30 weeks
- Axillary temperature ,37.5 Degrees
- informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy of suphladoxine/pyrimethamine as IPTpAlso: Fansidar3 tablets (single dose)given twice during pregnancy one month apart after quickening | Drug | SP-IPTp efficacy |
| Efficacy of suphladoxine/pyrimethamine as IPTpAlso: Fansidar2 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 | Drug | SP-IPTp efficacy |
Primary outcome
To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women
Time frame: 15 months
PCR corrected Adequate parasitological clearance by day 42
2 secondary outcomes
To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women
Time frame: 15 months
To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ebenezer Baba contact
Dr Elvis Shu contact
Daniel Chandramohan, PHD study chair
London School of hygeine and tropical medicine
Elvis N Shu, PHD principal investigator
College of Medicine, University of Nigeria , Enugu Campus
Ebenezer S Baba, MBBS, MPH study director
Malaria Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efficacy of suphladoxine/pyrimethamine as IPTp in people with Pregnancy Complications Parasitic, run by Malaria Consortium, UK at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ebenezer Baba, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.