N/A
N=42
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT04666350 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Oocyst Prevalence — 5.2; 6.3; 2.3; 2.2 percentage of mosquitoes — p=0.711
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Direct Skin Feeding Assay (DSFA) (Other); Primaquine (Drug); Artemether/Lumefantrine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oocyst Prevalence |
5.2; 6.3; 2.3; 2.2 | 0.711 |
| SECONDARY Oocyst Density |
1.1; 1.6; 0.4; 0.4 | 0.019 sig |
| SECONDARY Sporozoite Prevalence |
5.1; 4.5; 1.8; 2.0 | 0.750 |
| SECONDARY Sporozoite Density |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04666350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.