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A clinical trial of patient adherence and treatment outcome in supervised versus non-supervised artesunate/sulphadoxine - pyrimethamine treatment in uncomplicated falciparum malaria

A comparative study of patient adherence vis-à-vis treatment outcome in supervised versus non-supervised artesunate/sulphadoxine - pyrimethamine administration in uncomplicated falciparum malaria

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/10/005105
Enrollment
62
Registered
2014-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria

Interventions

Intervention1: artesunate sulphadoxine-pyrimethamine supervised or non-supervised: sulphadoxine-pyrimethamine,primaquine either in supervised or non-supervised therapy Intervention2: artesunate sulpha

Sponsors

Dr Chiranjib Bagchi Calcutta School of Tropical Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria • Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P falciparum parasites only (without mixed infection). • Only those of the above patients considered eligible by the physician at the Malaria Clinic, for dispensation of AS-SP plus primaquine treatment as per the national guidelines (NVBDCP). • Adult patients (age > 18 years) â?? both sexes • Patients willing to give informed consent. • Patients considered able to comply with the study protocol for the duration of the study. • Patients residing within a reasonable distance of the site, so that attendance of all study visits and follow-up by medical staff are logistically feasible.

Exclusion criteria

Exclusion criteria: Exclusion Criteria • Mixed infection with another Plasmodium species at the time of presentation (including P vivax, P ovale and P malariae) • Known allergy to artesunate, artemisinin derived products, sulphadoxine, pyremethamine, primaquine or any other related drugs. • G6PD deficiency as investigated by the G6PD test

Design outcomes

Primary

MeasureTime frame
Adherence of patients to artesunate/sulphadoxine-pyrimethamine treatmentTimepoint: Adherence, Serum antimalarial estimation- on Day 3

Secondary

MeasureTime frame
Compare efficacy and tolerabilityTimepoint: Day 0,3,7,28

Countries

India

Contacts

Public ContactDr Chiranjib Bagchi

Calcutta School of Tropical Medicine

tripathi.santanu@gmail.com9230566771

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026