Status:
COMPLETED
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays
Lead Sponsor:
PATH
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute
Conditions:
Malaria
Eligibility:
All Genders
18-55 years
Brief Summary
The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.
Detailed Description
The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval. The results will determine the type...
Eligibility Criteria
Inclusion
- Provision of signed or thumb printed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female aged between 18 years and 55 years inclusive.
- Resident within the study area
- In good general health as evidenced by medical history and clinical examination before entering the study Ability to take oral Coartem and low-dose primaquine anti-malarials upon conclusion of day 2 (2nd direct skin feed) and be willing to adhere to the medication regimen
- For females, she must be of non-childbearing potential or use appropriate measures to prevent pregnancy for 30 days after receiving Coartem and primaquine. Non-childbearing potential means she is surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or Depo-Provera).
- For males, he must be willing to ensure that he does not get his partner(s) pregnant for at least 3 months after treatment with primaquine. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions in either the participant or the partner.
- Positive for P. falciparum gametocytes as measured by polymerase chain reaction (PCR) with cycle threshold (cT) value \< 31.
Exclusion
- Presence of any signs or symptoms of malaria
- Presence of contraindications to administration of Coartem and primaquine as indicated in the respective drug package inserts
- History of severe allergic reactions to mosquito bites (other than pruritus and local swelling)
- Pregnant (i.e. a positive pregnancy test)
- Current or recent (within the preceding 2 weeks) use of antimalarial treatment
- Current participation in a malaria vaccine study
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Key Trial Info
Start Date :
March 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04666350
Start Date
March 9 2021
End Date
December 20 2021
Last Update
April 29 2024
Active Locations (1)
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1
KEMRI
Kombewa, Kenya