Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

Launched by UNIVERSITEIT ANTWERPEN · Jun 15, 2011

Keywords

ClinConnect Summary

RATIONALE Following the World Health Organization (WHO) guidelines, most African countries have opted for ACT. Several clinical trials on ASAQ, an ACT, completed in Africa have shown an efficacy \> 90% (3-5). Furthermore, after The polymerase chain reaction (PCR) analysis, over 75 % of ASAQ \& AL treatment failures have been classified as new infections, while recrudescences have low parasite densities. ASAQ is safe and easy administered, with a good treatment adherence. Therefore, effectiveness may be close to efficacy . ASAQ has now been developed as fixed-dose combination and registered....

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have been enrolled in the first phase
• • 2. Recurrent Plasmodium falciparum infection with clinical symptoms.
• • 3. Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the study.
• • 4. Signed (or thumb-printed whenever parents/guardians are illiterate) (second) informed consent by the parents or guardians. Note: the informed consent will cover the whole period of the study, including additional active follow ups
• Exclusion Criteria:
• Patients with at least one of the following criteria will be excluded:
• • 1. Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
• • 2. Known hypersensitivity and previous Serious Adverse Events related to the study drugsto the study drugs.
• • 3. Severe malaria( WHO 2000) or danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.
• • 4. Presence of intercurrent illness or any condition (cardiac, renal, hematologic, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency.
• • 5. Patients who are taking drug which may prolong the QT (imidazole and triazole, antifungal agent).
• • 6. Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
• • 7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women.