Therapeutic Efficacy studies of ACT for Plasmodium faciparum malaria

Not Applicable

• Conditions: Health Condition 1: B509- Plasmodium falciparum malaria, unspecified

• Registration Number: CTRI/2018/10/015936
• Lead Sponsor: WHO through WR India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

age between minimum age 1 year to maximum age 65 years

mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);

parasitaemia of (1000)â??(100000)/µl asexual forms

presence of axillary or tympanic temperature >= 37.5 °C or oral or rectal temperature of >= 38 °C or history of fever during the past 24 h;

ability to swallow oral medication;

ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;

informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority;

informed assent from any minor participant aged from 12 to age of majority years; and

Only if consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) and from their parent or guardian if under the age of majority years.

Exclusion Criteria

presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO

weight under 5 kg;

haemoglobin < 8g/dl;

mixed or mono-infection with another Plasmodium species detected by microscopy;

presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below â??3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm);

presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);

•regular medication, which may interfere with antimalarial pharmacokinetics;

•history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

•a positive pregnancy test or breastfeeding; and

•unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age > 12 years and sexually active).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the clinical and parasitological efficacy of AL in patients aged between above 1 year and maximum 65 years, suffering from uncomplicated falciparum malaria, by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy <br/ ><br>Timepoint: To measure the clinical and parasitological efficacy of AL in patients aged between above 1 year and maximum 65 years, suffering from uncomplicated falciparum malaria, by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
â?¢To determine the polymorphism of molecular markers for ACT RESISTANCETimepoint: 28 days