Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections

NCT03814616

Malaria,Falciparum

UNKNOWN PHASE2

Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria

NCT00440999

Malaria

COMPLETED PHASE3

Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria

NCT02389439

Malaria, Falciparum

COMPLETED PHASE2

Pharmacokinetic Study of Primaquine and Pyronaridine-Artesunate in Healthy Subjects

NCT01552330

Healthy

COMPLETED PHASE1

Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria

NCT05750459

Plasmodium Falciparum Infection

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase II, open-label, sequential-group, dose-escalation, single-centre study to study pharmacokinetics, bioavailability comparison of tablets vs. granules, and safety/tolerability of PA in paediatric patients with acute symptomatic uncomplicated P. falciparum malaria. The study population will include 60 patients, comprising male and female children recruited from a single study site located in the endemic region of Gabon.

Patients will be assigned sequentially to 1 of 4 treatment groups (15 per group): Group A (Tablets) PA (48 mg + 16 mg), Group B (Tablets) PA (72 mg + 24 mg), Group C (Tablets) PA (96 mg + 32 mg), Group D (Granules) PA (60 mg + 20 mg). Oral tablets will be taken once daily for 3 consecutive days (Days 0, 1 and 2). The dose given to each patient depends on the dosing cohort group and the patient's body weight.

Each patient will attend the study site for screening and baseline procedures, as well as receipt of the first dose of study drug on Day 0 (Visit 1, baseline). Patients will be hospitalised for the first 72 hours and remain near the study site for the entire duration of the study. The patients will return to the study site for all scheduled follow-up visits until discharge on Day 42.

The primary efficacy end point for the study is the incidence of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uncomplicated Plasmodium Falciparum Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A (Tablets)

Pyronaridine artesunate 6:2 mg/kg. The tablet strength is 48:16 mg oral PA, with the number of tablets depending on body weight.

Group Type EXPERIMENTAL

Pyronaridine-Artesunate

Intervention Type DRUG

Once a day for 3 days

Group B (Tablets)

Pyronaridine artesunate 9:3 mg/kg. The tablet strength is 72:24 mg oral PA, with the number of tablets depending on body weight.

Group Type EXPERIMENTAL

Pyronaridine-Artesunate

Intervention Type DRUG

Once a day for 3 days

Group C (Tablets)

Pyronaridine artesunate 12:4 mg/kg. The tablet strength is 96:32 mg oral PA, with the number of tablets depending on body weight.

Group Type EXPERIMENTAL

Pyronaridine-Artesunate

Intervention Type DRUG

Once a day for 3 days

Group D (Granules)

Pyronaridine artesunate 9:3 mg/kg. The sachet of granules strength is 60:20 mg PA, with the number of sachets depending on body weight, and is administered as a suspension with water.

Group Type EXPERIMENTAL

Pyronaridine-Artesunate

Intervention Type DRUG

Once a day for 3 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pyronaridine-Artesunate

Once a day for 3 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pyramax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female children, being between 2 and 14 years of age inclusive
* Weight between 10 and 40 kg inclusive
* Written informed consent, in accordance to local practice, provided by parent/guardian. If the parent/guardian is unable to write, witnessed consent is permitted according to local ethical considerations. Where possible, parent assent will be sought
* Absence of severe malnutrition (defined as mid upper arm circumference \<110mm)
* Presence of acute symptomatic uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only (i.e. no mixed infection) plus measured temperature of ≥37.5°C (depending on method of measurement as below) or history of fever within the past 24 hours :
* the acceptable range is between 1,000 and 200,000 asexual parasite count/μl of blood and
* axillary/tympanic temperature of ≥37.5°C or oral/rectal temperature of ≥38.0°C
* Females of childbearing potential are not allowed to be pregnant or lactating and must be willing to use adequate measures of contraception during the study period
* Ability to comply with the study visit schedule and the study protocol for the duration of the study

Exclusion Criteria

* Patients with signs and symptoms of severe/complicated malaria requiring parenteral antimalarial treatment according to the WHO Criteria 2000
* Mixed Plasmodium infection
* Severe vomiting, defined as \>3 times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as \>3 watery stools per day
* Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
* Presence of febrile conditions caused by diseases other than malaria
* Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
* Use of any other antimalarial treatment within 2 weeks prior to start of the study as confirmed by Lignin test and Saker Solomon urine test
* For females of childbearing potential, positive urine pregnancy test or lactating
* Use of an investigational drug within the past 8 weeks
* Known active Hep A immunoglobulin, Hep B surface antigen, or Hep C antibody
* Known seropositive HIV antibody
* Liver function tests (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] levels) \>3 times the upper limit of normal
* Known significant renal impairment as indicated by a serum creatinine ≥2 mg/dL
* Previous participation in this clinical study

Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No