Biological Mechanisms in Afebrile P. Falciparum Malaria

NCT04422015 | Completed

• 1 other identifier: 1R01AI150521
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Falciparum Malaria

Keywords

afebrile; resistance; tolerance

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals developing fever

  Development of axilary temperature higher or equal than 37.5ºC

  1 month

Secondary Outcomes (2)

• Proportion of individuals clearing the infection

  1 month

• Proportion of individuals maintaining infections without fever

  1 month

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals (temperature below 37.5ºC) with a P. falciprum infection confirmed by RDT and microscopy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alfredo Mayor: lead
• Centro de Investigação em Saúde de Manhiça: collaborator
• Stanford University: collaborator
• University of Florida: collaborator

Study Sites (1)

Fundação Manhiça/Manhiça Health Research Center

Manhiça, 1929, Mozambique

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Research Professor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: March 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

MO (1)