Experimental Falciparum Transmission to Anopheles (EFITA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02431637|
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Biological: Administration of the malaria inoculum Drug: Piperaquine Phosphate 480 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blood Stage Challenge Study to Asses Mosquito Transmissibility in Participants Inoculated With Plasmodium Falciparum|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Piperaquine Phosphate after infected blood malaria challenge
Volunteers will receive a dose of 480 mg piperaquine phosphate (PQP) approx. 7 days after a challenge with P. falciparum infected red blood cells. The effects of PQP on gametocyte carriage (assessed by PCR) and infectivity to mosquitos after direct and indirect feeding on blood from volunteers will be assessed.
Biological: Administration of the malaria inoculum
Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.
Drug: Piperaquine Phosphate 480 mg
When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate
- Successful infection of vector mosquitoes following both direct and indirect feeding on the blood of infected participants [ Time Frame: 7-10 days after blood feeding ]Seven to ten days after blood feeding, mosquitoes will be dissected to check for oocysts in midgut preparations. For permanent preparations, oocysts will be stained with 0.1% mercurochrome in PBS for 5 to 60 mins then fixed in 1%glutaraldehyde or formaldehyde. Oocysts will be counted per mosquito dissected and recorded. Relationship between parasitemia, gametocytemia and mosquito infection (both oocyst prevalence and intensity) will be determined using generalized-linear mixed models. The number of mosquitoes dying prior to dissection will be recorded.
- Safety and Tolerability - AEs and SAEs [ Time Frame: Blood stage Plasmodium falciparum Challenge Inoculum up to Day 31 ]Adverse events and SAEs: incidence, study drug (and inoculum) relatedness and severity
- Safety and Tolerability - Vital signs [ Time Frame: Blood stage Plasmodium falciparum Challenge Inoculum up to Day 31 ]Vital signs
- Safety and Tolerability - ECGs [ Time Frame: Blood stage Plasmodium falciparum Challenge Inoculum up to Day 31 ]ECGs
- Safety and Tolerability - Laboratory tests [ Time Frame: Blood stage Plasmodium falciparum Challenge Inoculum up to Day 31 ]Safety laboratory tests
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): NCT02431637
|Herston, Queensland, Australia, 4006|
|Principal Investigator:||James McCarthy, Prof||QIMR Berghofer Medical Research Institute|