Therapeutic Efficacy studies of antimalarial in India

Not Applicable

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

• Registration Number: CTRI/2019/07/020186
• 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 above 1 year to 65 years

Mono infection with P. falciparum detected by microscopy

parasitaemia of 1,000â??100,000/µl asexual forms

presence of axillary >= 37.5 °C or history of fever during the past 48 hrs

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

informed assent from any minor participant aged from 12 to age of majority (18 years old) and

consent for pregnancy testing from female of child-bearing age and from their parent or guardian if under the age of majority 18 years old

Exclusion Criteria

presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO

female aged from 12 years and age of majority

weight under 5 kg

haemoglobin < 8 g/dl

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

presence of severe malnutrition,

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) (select one or more of the three options, and delete those that are not applicable)

presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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); and

a positive pregnancy test or breastfeeding;

unable to or unwilling to take contraceptives 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 AS+SP 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 efficacyTimepoint: 28 days followup period and the proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction analysis. <br/ ><br>

Secondary Outcome Measures

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