To Study effectiveness and safety of Anti-malarial drug on uncomplicated falciparum malaria

Phase 4

Completed

• Conditions: Health Condition 1: null- acute uncomplicated P. falciparum malaria

• Registration Number: CTRI/2014/01/004286
• Lead Sponsor: Ranbaxy Laboratories Ltd

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: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive Rapid Diagnostic Test (RDT) for P. Falciparum.

Presence of fever (>= 99 °F) or a documented history of fever in the past 24 hours.

Exclusion Criteria

Patients not willing to provide written informed consent for participation in clinical study.

Patients with severe malaria namely, impaired consciousness, convulsions, jaundice, bleeding, pulmonary edema or requires hospitalization

Mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae).

Age 12 or 65 years

Known allergy to artesunate, artemether, artemisinin derived products, lumefanterine, piperaquine or any other related drug.

Patients with significant renal or hepatic impairment

Pregnant and Lactating women

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ï?¼The percentage of patients being â??afebrileâ?? and Blood Smear Negative at end of 3 days of treatment with SynriamTimepoint: ï?¼The percentage of patients being â??afebrileâ?? and Blood Smear Negative at end of 3 days of treatment with Synriam

Secondary Outcome Measures

Name	Time	Method
ï?¼Safety and tolerability by evaluating the incidence and severity of adverse events (AEs), and abnormal laboratory values through the <br/ ><br>o3 days of treatment with Synriam and <br/ ><br>oDay 28 of Observation period. <br/ ><br>Timepoint: day 3 and day 28;ï?¼The percentage of patients with â??aparasitemiaâ?? on Day 28 of the Observation period, on blood smear examination for minimum of 100 patients.Timepoint: day 28;ï?¼The percentage of patients with â??feverâ?? and Blood Smear Positive for P. Falciparum during 28 Days of the Observation periodTimepoint: day 28