Uncomplicated malaria
Conditions
Interventions
An observational, prospective study with two arms
the first aims to evaluate the kinetics of parasitic elimination in vivo and in vitro and the presence of genetic polymorphisms associated with decreased clearance time of P. falciparum in adult patie
Sponsors
Instituto Nacional de Infectologia Evandro Chagas
Instituto Nacional de Infectologia Evandro Chagas
Eligibility
Inclusion criteria
Inclusion criteria: Arm I Inclusion criteria • Male or women, > 18 years old; • Acute malaria not complicated by P. falciparum confirmed by thick drop with asexual forms of P. falciparum; • Parasitic density between 500-100,000 / uL of blood at the time of screening; • Axillary > 37.5 ° C or history of fever in the last 24 hours; • Informed written consent; • Ability to swallow oral medication; • Willingness and ability to meet the study schedule for the duration of the study. Arm II: Inclusion criteria Man or woman, regardless of age; Symptomatic malaria falciparum confirmed by (i) positive thick gout with asexual forms of P. falciparum; or (ii) rapid test (RDT) based on LDH, or by (iii) polymerase chain reaction (PCR), HRP2-based AND (iv) HRP2 based RDT; Axillary temperature > 37.5 °C or history of fever in the last 24 hours; Informed consent in writing; Ability and willingness to comply with the study protocols (for the duration of the study and meet the study visit schedule.
Exclusion criteria
Exclusion criteria: Arm I Exclusion criteria • Presence of general signs of danger / complicated falciparum malaria, according to who 2015 definitions; • Hematocrit <25% or hemoglobin <8 g/dL at screening; • Mixed infection or mono-infection with another Plasmodium species detected by microscopy; • Presence of febrile conditions due to diseases other than malaria (measles, acute infection of the lower respiratory tract, severe diarrhea with dehydration); • Presence of known underlying chronic or serious diseases (e.g.: heart, kidney, liver, HIV/AIDS) diseases • For women of childbearing age [18-45 years]: positive pregnancy test or breastfeeding; • Receipt of antimalarial drugs in the previous 48 hours; • History of known allergy or contraindication to ASMQ; • Unable to perform the pregnancy test; • Previous splenectomy; Arm II Exclusion criteria Have been included in the study previously (Arm II); Have not been tested with HRP2-based RDT; Refuse the collection of the biological samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study the clinical and molecular epidemiology of falciparum malaria infection in an endemic region of the Brazilian Amazon basin, including the kinetics of parasite clearance, the presence of mutations associated with decreased clearance time, the genetic marker of pfhrp2/3, and its impact on therapeutic and parasitological response | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantify the kinetics of parasite clearance in vivo and in vitro using a standardized parasite clearance estimator among adult patients with uncomplicated falciparum malaria treated with ASMQ FDC Estimate the prevalence of the mutation in P. falciparum pfhrp2/3 genes among symptomatic individuals with P. falciparum infection Measuring parasitic density, measured by quantitative PCR and/or microscopy in patients with suspected falsely negative pfhrp2/3 Measure the clinical and parasitological efficacy of the ASMQ FDC tablet in patients aged 18 years or older, with uncomplicated falciparum malaria, determining the proportion with early treatment failure, late clinical failure, late parasitological failure, or appropriate clinical and parasitological response as indicators of efficacy Differentiate recrudescence from new infection by polymerase chain reaction analysis Assess the safety and tolerability of ASMQ FDC tablets Evaluate fever whitening rates of ASMQ FDC tablets Assess the spread of artemisinin genetic markers (such as Kelch 13 mutations) and drug resistance partners Measure the incidence and duration of gametocyte transport in patients with sensitive malaria and antimalarial before and after treatment with ASMQ Evaluate the in vitro sensitivity of P. falciparum to artesunate antimalarials, mefloquine, and the FDC ASMQ Evaluate the in vitro clearance time of the parasite P. falciparum after incubation with AS, using the ring-stage survival assay (RSA) Evaluate serum levels of host-produced cytokines during P. falciparum infection Evaluate humoral response to specific antigens for plasmodium proteins Establish a biorepository of clinically well-characterized samples for further development of tools to aid in the early identification of parasites with resistance to artemisinin derivatives | — |
Countries
Brazil
Contacts
Public ContactJosé Moreira
Outcome results
None listed