Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01055002
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2010-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study to Test Activity of Antimalarial Drugs Against an Induced Malaria Infection in Healthy Volunteers
Sponsor:
Medicines for Malaria Venture
Organization:
Study Overview
Official Title:
A Pilot Phase II Study of the Efficacy of Antimalarial Drugs Against Plasmodium Falciparum by Experimental Challenge With a Low Dose of Blood Stage Parasites in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study of a protocol for inducing a falciparum malaria infection in healthy volunteers in order to test the activity of novel agents being developed as drugs for the treatment of uncomplicated malaria. In this pilot study, 16 healthy male volunteers will be administered a low level malaria infection via infected human red blood cells. After 6 days they will be administered one of two registered antimalarial treatments (8 volunteers for each treatment) in order to define the rate of clearance of the infection. This information will be used to design similar future studies for the initial assessment of the efficacy of novel antimalarial drugs in development.
Detailed Description:
This is a single-center, controlled, randomized, study using a BSP inoculum challenge as a model to assess the activity of antimalarial agents. The study will be conducted in 2 cohorts (n = 6 and n = 10). Cohort 2 will not commence until at least after day 12 of cohort 1 and review by Safety Review Team following day 9 exit of cohort 1. The participants will be randomized 1:1 to the two registered antimalarials. This is an enabling study using registered antimalarial drugs as reference treatments (one slow acting and one fast acting), aimed to inform trial design, endpoints and testing regimens for assessing new candidate antimalarial drugs in development. The study will follow the sequence of the challenge inoculation, reference treatment and follow-up.
Healthy male participants will be inoculated on Day 1 with \~1,800 Plasmodium falciparum-infected human erythrocytes administered intravenously. On an outpatient basis, participants will be monitored morning (AM) and night (PM) from day 3 to day 5 for adverse events and the unexpected early onset of symptoms, signs or parasitological evidence of malaria. On day 5 evening, participants will be admitted to the study unit and confined for safety monitoring and antimalarial treatment. Reference treatment administration will begin on the evening of Day 6 and continued on Day 7 and 8 (3 days of treatment).
If clinical or parasitologic evidence of malaria (either the identification of two or more malaria parasites on a malaria thick film, platelet count less than 100 x109/L, or the onset of clinical features of malaria) occurs before day 6 evening, allocated treatment will begin at this time.
Following treatment, participants will be followed up as inpatients for at least 86 hours, (4 evenings) to ensure tolerance of the therapy and clinical response, then if clinically well on an outpatient basis for safety and continued presence of malaria parasites via PCR and thick blood film review.
Adverse events will be monitored via telephone monitoring, within the clinical research unit and on outpatient review after malaria challenge inoculation and antimalarial study drug administration. Blood samples for safety evaluation, malaria monitoring, and red blood cell antibodies will be drawn at baseline and at nominated times after malaria challenge.
Healthy male participants will be inoculated on Day 1 with \~1,800 Plasmodium falciparum-infected human erythrocytes administered intravenously. On an outpatient basis, participants will be monitored morning (AM) and night (PM) from day 3 to day 5 for adverse events and the unexpected early onset of symptoms, signs or parasitological evidence of malaria. On day 5 evening, participants will be admitted to the study unit and confined for safety monitoring and antimalarial treatment. Reference treatment administration will begin on the evening of Day 6 and continued on Day 7 and 8 (3 days of treatment).
If clinical or parasitologic evidence of malaria (either the identification of two or more malaria parasites on a malaria thick film, platelet count less than 100 x109/L, or the onset of clinical features of malaria) occurs before day 6 evening, allocated treatment will begin at this time.
Following treatment, participants will be followed up as inpatients for at least 86 hours, (4 evenings) to ensure tolerance of the therapy and clinical response, then if clinically well on an outpatient basis for safety and continued presence of malaria parasites via PCR and thick blood film review.
Adverse events will be monitored via telephone monitoring, within the clinical research unit and on outpatient review after malaria challenge inoculation and antimalarial study drug administration. Blood samples for safety evaluation, malaria monitoring, and red blood cell antibodies will be drawn at baseline and at nominated times after malaria challenge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: