Malarial Immunity in Pregnant Cameroonian Women
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ClinicalTrials.gov Identifier: NCT00593398 |
Recruitment Status
: Unknown
Verified December 2010 by University of Hawaii.
Recruitment status was: Recruiting
First Posted
: January 15, 2008
Last Update Posted
: December 14, 2010
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Condition or disease |
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Plasmodium Falciparum Malaria |
Study Type : | Observational |
Estimated Enrollment : | 1376 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Malarial Immunity in Pregnant Cameroonian Women |
Study Start Date : | September 2008 |
Estimated Primary Completion Date : | September 2012 |
Estimated Study Completion Date : | September 2013 |


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Ages Eligible for Study: | up to 50 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Pregnant women who will be followed longitudinally during pregnancy:
- Greater than or equal to 15 years of age.
- Willingness to provide informed consent.
- Confirmed pregnancy.
- All gestational ages. Women less than 16 weeks of pregnancy will be enrolled, but they will not receive intermittent preventive therapy using sulfadoxine plus pyrimethamine (IPT-SP) until the 16th week of pregnancy or thereafter.
- Long-term residence in Yaounde, Ngali II or Ntouessong.
- Willingness of a women residing in Yaounde to release HIV testing results, obtained through a service provided by the MOH, to Dr. Leke, Cam-PI.
- Women residing in Ngalii II and Ntouessong will be encouraged to be HIV tested and asked to provide data on their HIV status to the project. However, HIV testing and providing the results will be optional.
Pregnant women enrolled near term:
- Same as above.
- Women who have a health booklet with entries entered by a physician/midwife/pharmacist about antimalarial treatment they have received during pregnancy
Inclusion criteria for infants living in Ngali II and Ntouessong:
- Resident of Ngali II or Ntouessong.
- Willingness of the mother/caregivers to give informed consent for their babies.
- Agree to bring the baby to the clinic whenever s/he becomes ill. Alternatively, inform the designated staff member or village health care worker that the baby is ill.
- Willingness to bring the baby for all recommended routine child-hood immunizations.
- Agree to provide a stool sample from the baby when s/he is 6 and 12 months of age.
- Twins will be included in the study.
Exclusion Criteria:
Pregnant Cameroonian women following longitudinally during pregnancy:
- Women who report a history of allergic reactions to sulfamides
- Women who report reactions to previously unknown antimalarial drugs
- Women with serious liver attacks (e.g., chronic hepatitis) or kidney failure or neurological conditions (e.g., seizures).
- Women with history of skin allergies
- Other conditions that in the opinion of the Director of Clinical Studies (DCS) or clinical staff (CS) would jeopardize the safety and rights of a participant in the trial or would render the participant unable to comply with the protocol.
Pregnant women enrolled near term:
Infants living in Ngali II and Ntouessong:
- Vague or incomplete information on maternal use of anti-malarials during pregnancy.
- Failure to inform the project staff that they are about to, or have delivered their babies, thereby preventing access to baseline information and specimens at birth that are critical for conduct of the study.
- Other conditions that in the opinion of the DCS, CS, or Cam-PI would jeopardize the safety and rights of a participant in the trial or would render the participant unable to comply with the protocol.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593398
Contact: Diane W Taylor, PhD | (808) 692-1806 |
Cameroon | |
University of Yaounde 1 | Recruiting |
Yaounde, Cameroon | |
Contact: Rose G.F. Leke, PhD roseleke@yahoo.com | |
Principal Investigator: Rose FG Leke, PhD |
Principal Investigator: | Diane W Taylor, PhD | University of Hawaii |
Responsible Party: | Paul Kakugawa, Administrative Officer |
ClinicalTrials.gov Identifier: | NCT00593398 History of Changes |
Other Study ID Numbers: |
07-0010 |
First Posted: | January 15, 2008 Key Record Dates |
Last Update Posted: | December 14, 2010 |
Last Verified: | December 2010 |
Keywords provided by University of Hawaii:
Malaria pregnant women infants Cameroon |
Additional relevant MeSH terms:
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases |