Mozambikli Çocuklarda Artemether-lumefantrine ve Amodiaquine-artesunate'in İn Vivo Etkinliği (MEFI_III)

Sade dilde özet

Bu çalışma, Mozambikli çocuklarda sıtma (malaria) tedavisinde kullanılan Artemether-lumefantrine (Coartem) ve Amodiaquine-artesunate (Winthrop) ilaç kombinasyonlarının etkinliğini inceledi. Katılım için 6-59 ay arası, mikroskopi ile doğrulanmış Plasmodium falciparum sıtması olan çocuklar aranıyordu. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

Centro de Investigacao em Saude de Manhica

Müdahale

Coartem™ (Artemether-lumefantrine combination), Winthrop™ (Amodiaquine-artesunate combination)

Başlangıç

21.03.2018

Tahmini bitiş

19.12.2019

Ülkeler

Mozambique

İlgili genler

Merkezler

• Montepuez, Mozambique
• Massinga, Mozambique
• Manhiça, Mozambique
• Manhiça, Mozambique
• Moatize, Mozambique
• Mopeia, Mozambique

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Ages 6 to 59 months
* Weight Greater than or equal to 5 kg
* Absence of severe malnutrition;
* Mono-infection with Plasmodium falciparum in blood, confirmed by microscopy;
* Parasite density between 2,000 and 200,000 asexual parasites per microliter of blood;
* Axillary temperature ≥ 37.5 C° or history of fever in the last 24 hours;
* Lack of danger signs, or no signs of severe and / or complicated malaria according to the WHO definition
* Ability to swallow the drugs
* Haemoglobin greater than 5.0 g / dl
* Residents within the study area and have the possibility of an adequate follow-up in the days of monitoring for a period of 28 days;
* Absence of a history of hypersensitivity to study medications;
* Informed consent of parents, guardians or caregivers (legal guardian) after explaining the purpose of the study.

Exclusion Criteria:

* Presence of any danger sign or severe or complicated Plasmodium falciparum malaria according to WHO definitions
* Presence of fever due to diseases other than malaria (eg measles, acute respiratory infection, severe diarrhea with dehydration) or other known diseases, with chronic or serious illnesses (cardiac, renal, hepatic or known infection with HIV AIDS),
* Presence of severe malnutrition (defined as a child whose growth pattern is below the 3rd percentile, mid-upper-arm circumference \<110mm, weight / height \<70% according to the WHO tables, or the presence of bilateral edema of the lower limbs)
* Multi or mono-infection by another Plasmodium species detected by microscopy;
* Regular medication that may interfere with the pharmacokinetics of antimalarials;
* History of hypersensitivity or contraindication to study drug;
* A history of taking antimalarial drugs or drugs with antimalarial activity in less than 7 days.
* Continuous prophylaxis with cotrimoxazole in HIV positive children