Research

Malaria Research Project

National Institute of Malaria Research (NIMR) - a division of the Indian Council of Medical Research, in association with Ranbaxy has been conducting research in malaria in four centres all over the world. Tata Main Hospital is a proud associate in NIMR’s expanding territories of research work. The study at TMH was on a phase II Trial of Arterolane (RBx 11160) Maleate + Piperaquine Phosphate combination in adult patients with acute uncomplicated P. falciparum malaria. The main purpose of the trial was to compare efficacy and safety of Arterolane maleate and PQP combination with Coartem.

Efficacy Parameters were

• Day 28 PCR corrected ACPR (Adequate Clinical and Parasitological Response)
• PCT (Parasite Clearance Time)
• FCT (Fever Clearance Time)

Safety Parameters were

• Adverse events
• Laboratory assessments
• ECG

The dosage for the adult patient was Arterolane maleate 150 mg co-administered with PQP 750 mg tablets once daily for 3 days. The dosage for Coartem^® tablets (each tablet containing fixed dose combination of artemether 20 mg and lumefantrine 120 mg) was a total of 4 tablets twice a day for 3 days.

Patients Enrolled in Phase II Trial comprises 65 patients from TMH, 5 from Ranchi, 76 from IGH Rourkela and 94 patients from Bangkok.

Initial parasite clearance achieved in all the recruited patients:

• Day 28 parasite clearance
• 151/151 patients with arterolane maleate+ PQP
• 78/79 patients with Coartem
• 1 treatment failure with Coartem - PCR analysis has confirmed recrudescence.

The new drug is well tolerated. All adverse events are either mild or of moderate intensity.

Phase III Trial of fixed dose combination of Arterolane Maleate and PQP in patients with P. falciparum malaria was conducted in 2009.