Monitoring the therapeutic efficacy of antimalarial medicines across International borders of India.

Phase 3

Recruiting

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12614000217606
• Lead Sponsor: ational Insititute of Malaria Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Age between 1 year to 65 years ; Mono infection with P. falciparum detected by microscopy, parasitaemia of (1000)–(100000)/microlitre asexual forms; presence of axillary great than or equal to 37.5 degrees celsius or history of fever during the past 48 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; and informed consent from the patient or from a parent or guardian in the case of children

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; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of severe malnutrition, 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); a positive pregnancy test or breastfeeding; and unable to or unwilling to take contraceptives (for women of child-bearing age).

Study & Design

• Study Type: Interventional
• Study Design: Not specified