nderstanding Plasmodium falciparum malaria in the Amazon: implications for the national malaria control program

• Conditions: ncomplicated malaria; Plasmodium falciparum; Brazil; Plasmodium falciparum histidine-rich protein-2 gene; therapeutic efficacy trial; Artemisinin-based combination therapy; Parasitological clearance rate

• Registration Number: RBR-634ymd5
• Lead Sponsor: Instituto Nacional de Infectologia Evandro Chagas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-23
• Study Completion: 2022-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified