to study how safe and effective KLU156 medicine is for patients with uncomplicated malaria

Phase 3

Recruiting

• Conditions: Health Condition 1: B509- Plasmodium falciparum malaria, unspecified

• Registration Number: CTRI/2024/06/068890
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia = 1,000 and = 200,000 parasites/µL at the time of pre-screening with or without other Plasmodium spp. co-infection.

2. Axillary temperature = 37.5 ºC or oral temperature = 38.0 ºC or tympanic/rectal temperature = 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally)

3. Negative pregnancy test for patients of childbearing potential

4.Signed informed consent must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parent/legal guardian consent or as per local ethical standards

5. The patient and/or their parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.

Exclusion Criteria

1.Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)

2.Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)

3.Severe malnutrition. For patients = 12 years: body mass index (BMI) < 16.0. For children < 12 years: less than 70% of median normalized WHO reference weight or very low mid-upper arm circumference (MUAC < 115 mm)

4.Repeated vomiting (defined as > 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as > 3 watery stools in the 24 hours prior to start of screening)

5.Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia

6.Anemia (hemoglobin level <7 g/dL)

7.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment), or which may jeopardize the patient in case of participation in the study.

8.Any of the following:

•Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) > 3 x the upper limit of normal (ULN), regardless of the level of total bilirubin

•Total bilirubin > 3 x ULN

•Resting QT interval corrected by Fridericia’s formula (QTcF) > 450 ms at screening

9.Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown)

10.History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease

11.Pregnant or nursing (lactating) patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To confirm the efficacy of KLU156 in adults and children = 5 kg body weight and = 2 months of age suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection)Timepoint: PCR-corrected adequate clinical and parasitological response (ACPR) at Day 29 (i.e., 28 days post-first dose administration)

Secondary Outcome Measures

Name	Time	Method
To compare the safety and tolerability profileTimepoint: Proportion of patients with parasitemia at 12, 24, 48 and 72 hours after treatment.;To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to CoartemTimepoint: Uncorrected ACPR at Day 29.