Afrikalı Çocuklarda Komplike Olmayan Sıtmanın Tedavisinde 4 Artemisinin Bazlı Kombinasyonun Değerlendirilmesi

Sade dilde özet

Bu çalışma, Afrikalı çocuklarda komplike olmayan sıtma (uncomplicated malaria) hastalığının tedavisinde artemisinin temelli dört farklı ilaç kombinasyonunu değerlendirmektedir. Çalışmaya, mikroskopla doğrulanmış Plasmodium falciparum sıtması olan, genellikle 6 ile 59 ay arasındaki bebek ve çocuklar katılabilmiştir. Institute of Tropical Medicine, Belgium tarafından yürütülen çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Institute of Tropical Medicine, Belgium

Müdahale

amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL), Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)

Başlangıç

01.07.2007

Tahmini bitiş

01.12.2009

Ülkeler

Burkina Faso, Gabon, Mozambique, Nigeria, Rwanda, Uganda, Zambia

İlgili genler

Merkezler

• Bobo-Dioulasso, Burkina Faso
• Lambaréné, Gabon
• Manhiça, Mozambique
• Calabar, Nigeria
• Kigali, Rwanda
• Kampala, Uganda
• Mbarara, Uganda
• Ndola, Zambia

Uygunluk kriterleri

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

Inclusion Criteria:

* Males and Females aged between 6 months and 59 months inclusive. In the sites where CDA is tested all recruited children will be aged between 12 months and 59 months inclusive (this arm was discontinued on 17th February 2008). This criterion applies only for the recruitment in the first follow up. For the second follow up, children having been included in the first follow up are eligible, regardless of their age.
* Body weight of 5 Kg and above.
* Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia ≥ 2,000/μL to 200,000/μL).
* Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
* Haemoglobin value ≥ 7.0 g/dl;
* Signed (or thumb-printed whenever parents/guardians are illiterate) informed consent by the parents or guardians. Note the informed consent will be asked only at recruitment and will cover the whole period of the study, including second active follow up and passive case detection.
* Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.

Exclusion Criteria:

* Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
* Known hypersensitivity to the study drugs.
* Severe malaria.
* 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.
* Presence of intercurrent illness or any condition (cardiac, renal, 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.
* Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
* Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carinii pneumonia in children born to HIV+ women.