Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar

• Status: Completed
• Trial end date: 2017-09-25
• Target enrollment: 0
• Participant gender: All

Summary

The general objective of this study is to assess the therapeutic efficacy and safety of artesunate + amodiaquine combined with a single low dose of primaquine (0.25 mg/kg) for the treatment of uncomplicated P. falciparum malaria patients in Zanzibar.

The specific objectives are:

• To determine the clinical and parasitological efficacy of artesunate + amodiaquine and primaquine in the treatment of uncomplicated Plasmodium falciparum infection.

• To differentiate recurrent infections during follow-up, i.e. recrudescence from new infections, by polymerase chain reaction (PCR).

• To evaluate the incidence of adverse events, particularly with regards to potential hematological adverse events of primaquine.

• To determine the polymorphism of molecular markers associated with artesunate + amodiaquine tolerance/resistance.

• To formulate recommendations, which will enable the Zanzibar Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated or not.

• To determine efficacy rate of the first line treatment compared to the first efficacy trial thirteen years ago.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Anders Björkman
• Collaborators: Ministry of Health and Social Welfare, Zanzibar; Uppsala University; Zanzibar Malaria Elimination Programme
• Treatments: Amodiaquine; Artemisinins; Artesunate; Primaquine

Criteria

Inclusion Criteria:

• Age 3 months and above;

• P. falciparum infection detected by malaria rapid diagnostic test (mRDT) and confirmed by microscopy;

• Presence of P. falciparum malaria asexual parasitaemia (any level);

• Presence of axillary ≥37.5 °C or history of fever during the past 48 hours

• Ability to swallow oral medication;

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

• Informed consent from the patient or from a parent or guardian in the case of children.

Exclusion Criteria:

• Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);

• Mono-infection with a Plasmodium species other than P. falciparum detected by microscopy;

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

• Regular medication, which may interfere with the study drugs;

• History of hypersensitivity reactions or contraindications to any of the study medicines; and

• Pregnancy