TES Artemether-lumefantrine for Pf and Chloroquine (CQ) for Pv

• Status: Completed
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: To assess the efficacy of the current first line of treatment policy.

Objectives:

To assess the safety and efficacy of Artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in the Philippines.

To assess the efficacy of Artemether-lumefantrine for the treatment of P. vivax infections in the Philippines.

Study Sites:

Rural Health Unit, Bataraza, Palawan Rural Health Unit, Rizal, Palawan

Study Design: one-arm, prospective study

Patient Population: Febrile patients aged > 6 months to 59 years old, with confirmed uncomplicated P. falciparum infection only or P. vivax infection only, and non- pregnant and/or breastfeeding for female.

Sample Size: A minimum of 50 and maximum of 75 patients will be enrolled for both Plasmodium falciparum and Plasmodium vivax malaria.

Treatments and follow-up: Clinical and parasitological parameters will be monitored over a 28/34 day follow-up period to evaluate drug efficacy.

Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicator of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis.

Secondary endpoints: The frequency and nature of adverse events.

Optional exploratory endpoints: to determine the polymorphism of molecular markers for name of the antimalarial drug(s) resistance.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Institute for Tropical Medicine, Philippines
• Collaborator: World Health Organization
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Chloroquine; Chloroquine diphosphate; Lumefantrine

Criteria

Inclusion Criteria:

• Above 6 months old to 59 years old;

• Mono-infection with P. falciparum or P. vivax, with parasitemia of: P. falciparum:

1000-100 000 asexual forms per µl; P. vivax : ≥ 250 per µl

• Axillary temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C;

• Ability to swallow medication;

• Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;

• Informed consent from the patient or from a parent or legal guardian in the case of children less than 18 years old;

• Informed assent from any minor participant aged 12 - 17 years; and

• Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years old.

Exclusion Criteria:

• Severe malnutrition

• Mixed Plasmodium species detected by microscopy;

• Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] <110 mm);

• Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);

• Regular medication, which may interfere with antimalarial pharmacokinetics;

• History of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment;

• Positive pregnancy test or breastfeeding; and

• Unable to or unwilling to take pregnancy test or to use contraception for women or child-bearing age and who are sexually active.