Efficacy and safety Study of Artesunate+Sulphadoxine/Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and Chloroquine for Plasmodium vivax malaria in health facilities of Nangarhar and Laghman provinces of Afghanista

Phase 4

Completed

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12622000944730
• Lead Sponsor: Ministry of Public Health Afghanistan

Brief Summary

One hundred twenty-three patients (63 from Laghman and 60 from Nangarhar) infected with P. falciparum were treated with artesunate+sulfadoxine/pyrimethamine (ASSP), and 120 patients with P. vivax (60 from Laghman and 60 from Nangarhar) were treated with chloroquine (CQ). The data from Nangarhar, for both the ASSP and CQ groups, were invalidated during blood sample quality control. Of the 60 patients treated with artesunate+sulfadoxine/pyrimethamine in Laghman, 57 met the study endpoints, and all had achieved adequate clinical and parasitological response. Similarly, all P. vivax patients treated with CQ achieved adequate clinical and parasitological response. No adverse events were recorded. No mutations for artemisinin, piperaquine, or mefloquine resistance were detected in samples form the patients with P. falciparum.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-02-11
• Study Start: 2022-07-04
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

1.age above 6 months, excluding female minors aged 12-15 years and unmarried women for the falciparum study
2.mono-infection with P. falciparum or P. vivax detected by microscopy;
3.parasitaemia of 500-200,000 per microL asexual forms
4.presence of axillary temperature greater or equal to 37.5 degrees centigrade or history of fever during the past 24 h
5.ability to swallow oral medication
6.ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
7.Informed consent from the patient, or from a parent or guardian in the case of children under 16 years of age
8.Informed assent from any minor participant in the P. falciparum study aged from 12 to 15 years
9.Consent for pregnancy testing from married female of child-bearing age for the P. falciparum sub-study

Exclusion Criteria

1.presence of general danger signs in children aged under 5 years and adults or signs of severe falciparum malaria according to the definitions of WHO
2.Weight under 5 kg
3.mono-infection of P. malariae or mixed with another Plasmodium species detected by microscopy
4.Presence of severe malnutrition (defined as a child who has a mid-upper arm circumference below 110 mm)
5.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)
6.regular medication, which may interfere with antimalarial pharmacokinetics;
7.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
8.a positive pregnancy test or breastfeeding for potential participants in the P. falciparum group
9.unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active for the falciparum group

Study & Design

• Study Type: Interventional
• Study Design: Not specified