A clinical trial to study the effects of artesunate - lumefantrine combination and artemether - lumefatrine combination in the treatment of uncomplicated Plasmodium falciparum malaria.

Phase 3

Completed

• Conditions: Uncomplicated Plasmodium falciparum malaria

• Registration Number: CTRI/2009/091/000434
• Lead Sponsor: Ipca Laboratories Limited

Brief Summary

This study is a randomised, double blind, parallel group, multicentre trial comparing the safety and efficacy of artesunate 100 mg + lumefantrine 480 mg with artemether 80 mg + lumefantrine 480 mg in the treatment of Indian patients with uncomplicated Plasmodium falciparum malaria. The patients will be hospitalized for 4 days. The follow up period is of 28 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 176

Inclusion Criteria

• Male and female patients with age between 18 to 65 years2.
• Patients clinically diagnosed of uncomplicated Plasmodium falciparum malaria with a diagnosis confirmed by positive blood smear with asexual forms of P.
• falciparum (parasite count between 1000 and 100,000 asexual parasites/µL of blood)3.
• Patients with axillary temperature >/= 37.5 °C and/or history of fever during past 24 hours4.
• Patients with clinical signs and symptoms of malaria5.
• Patients with satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.

Exclusion Criteria

• Patients with severe malaria as per WHO criteria 2.
• Patients with mixed malarial infection 4.
• Patients with abnormal heart function including history of QTc prolongation 5.
• Patients receiving any concomitant medication which may interact with study drugs 6.
• Patients who had taken full course of antimalarials within previous 3 days 7.
• Pregnant or lactating women 9.
• Women of child bearing potential.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adequate Clinical and Parasitological Response	Day 28

Secondary Outcome Measures

Name	Time	Method
Parasite Clearance Time	Day 1, Day 2 and Day 3
Fever Clearance Time	Day 1, Day 2 and Day 3

Trial Locations

Locations (6)

Government Medical College & New Civil Hospital, Surat; 🇮🇳 Surat, GUJARAT, India

Institute of Post Graduate Medical Education & Research; 🇮🇳 Kolkata, WEST BENGAL, India

LTMMC & MGH, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Sheth Vadilal Sarabhai General Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Smt. B. K. Shah Medical College & Dhiraj General Hospital; 🇮🇳 Vadodara, GUJARAT, India

Surat Municipal Institute of Medical Education & Research; 🇮🇳 Surat, GUJARAT, India

Government Medical College & New Civil Hospital, Surat

🇮🇳Surat, GUJARAT, India

Dr P B Gupta

Principal investigator

9426854798

drpbgupta@gmail.com