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

A prospective, open-label, multi-center, post marketing study to evaluate safety and efficacy of fixed dose combination (FDC) tablets of arterolane maleate and piperaquine phosphate (PQP) in Indian patients with acute uncomplicated falciparum malaria.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2014/01/004286

Enrollment

400

Registered

2014-01-06

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- acute uncomplicated P. falciparum malaria

Interventions

Intervention1: Synriam (Arterolane maleate 150mg and piperaquine phosphate 750mg): 3 day once daily treatment Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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 Â°F) or a documented history of fever in the past 24 hours.

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
ï?¼ Safety and tolerability by evaluating the incidence and severity of adverse events (AEs), and abnormal laboratory values through the o 3 days of treatment with Synriam and o Day 28 of Observation period. Timepoint: day 3 and day 28;ï?¼ The 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?¼ The percentage of patients with â??feverâ?? and Blood Smear Positive for P. Falciparum during 28 Days of the Observation periodTimepoint: day 28	—

Measure

Time frame

ï?¼ Safety and tolerability by evaluating the incidence and severity of adverse events (AEs), and abnormal laboratory values through the o 3 days of treatment with Synriam and o Day 28 of Observation period. Timepoint: day 3 and day 28;ï?¼ The 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?¼ The percentage of patients with â??feverâ?? and Blood Smear Positive for P. Falciparum during 28 Days of the Observation periodTimepoint: day 28

—

Countries

India

Contacts

Public ContactDr Mayuresh Fegde

sponsor personnel

mayuresh.fegade@ranbaxy.com09762037851

Outcome results

None listed

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