Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria (PLATINUM)
- Conditions
- Malaria
- Registration Number
- PACTR202302602361661
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 180
Signed informed consent must be obtained prior to participation in the study
Male and female patients =18 years of age for Part A and =12 years of age for Part B at screening
Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/µl of blood for P. falciparum for Part A and between 1,000 to 150,000 asexual parasite count/µl of blood for Part B
Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weigh between 35 kg and 90 kg at screening
Patients must be able to swallow oral medications
Able to communicate well with the investigator, to understand and comply with the requirements of the study
Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
AST/ALT > 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
AST/ALT > 1.5 and = 2 x ULN and total bilirubin is > ULN
Total bilirubin > 2 x ULN, regardless of the level of AST/ALT
Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception as outlined in Section 12, and sexually active patients not willing to practice effective contraception.
History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
History of familial long QT syndrome or known family history of Torsades de Pointe.
Resting heart rate (physical exam or 12 lead ECG) < 60 bpm
For full list, please reference protocol section 5.2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A - Parasite clearance time of oral doses of anti-malarial agents administered as monotherapy in patients with uncomplicated Plasmodium falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.;Part B - cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care in patients with uncomplicated P. falciparum malaria by using polymerase chain reaction PCR corrected adequate clinical and parasitological response ACPR. ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).
- Secondary Outcome Measures
Name Time Method