Falciparum Malaria Clinical Trial
— AsintMalOfficial title:
Unravelling Disease Tolerance and Host Resistance in Afebrile P. Falciparum Infections: a Prospective Study in Mozambican Adults
NCT number | NCT04422015 |
Other study ID # | 1R01AI150521 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | March 31, 2021 |
Verified date | August 2023 |
Source | Barcelona Institute for Global Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This project aims to disentangle the role of host immune resistance and disease tolerance in afebrile malaria infections, with the goal of guiding context-adapted tactics to target this hidden reservoir, as well as to develop new approaches to clear malaria infection and reduce its severity through host-directed therapies.
Status | Completed |
Enrollment | 475 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age = 18 years and =60 years - A positive RDT and microscopy for P. falciparum - Axillary temperature < 37.5ºC without history of fever during the last 24h - No danger signals for severe malaria (Impaired consciousness, respiratory distress, multiple convulsions, prostration, shock, abnormal bleeding, jaundice) - Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and - Signed informed consent after explaining the purpose of the study Exclusion Criteria: - Age <18 years or >60 years - Axillary temperature =37.5ºC - Reported pregnancy - Presence of any sign/symptom of malaria (Vomiting, diarrhea, weakness, dizziness, fainting, itching, urticarial) - Presence of any other co-existing clinical condition that would not allow the individual to be considered a "healthy" afebrile carrier - Having received antimalarial medication in the preceding 30 days. |
Country | Name | City | State |
---|---|---|---|
Mozambique | Fundação Manhiça/Manhiça Health Research Center | Manhiça |
Lead Sponsor | Collaborator |
---|---|
Alfredo Mayor | Centro de Investigação em Saúde de Manhiça, Stanford University, University of Florida |
Mozambique,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of individuals developing fever | Development of axilary temperature higher or equal than 37.5ºC | 1 month | |
Secondary | Proportion of individuals clearing the infection | Clearance of parasite infection as detected by qPCR | 1 month | |
Secondary | Proportion of individuals maintaining infections without fever | Confirmed P. falciparum ifection at day 28 by qPCR | 1 month |
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