A Phase 4 interventional study of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine in Malaria, sponsored by Epicentre. Completed at 1 site in Niger. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2015-11-30.
Sponsored by Epicentre · Phase 4, Interventional, and Treatment
Study treatments:
Location:
Maradi, Niger
Principal Objective:
To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment.
Secondary objectives:
Methods:
In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component.
Target population:
Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi.
Sample size:
221 patients per study treatment; 663 patients in total.
Treatment allocation:
Random.
Outcomes:
Analysis:
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 663 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.
Compared within Malaria, Falciparum, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Malaria. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Efficacy estimates at 95%
Drug: Artesunate-amodiaquine
Efficacy estimates at 95%
Drug: Dihydroartemisinin-piperaquine
Efficacy estimates at 95%
Drug: Artemether-lumefantrine
Drug pages: Artesunate · Amodiaquine
antimalarial ACT
Also known as: AS-AQ Winthrop® Sanofi Aventis
Drug pages: Artenimol · Piperaquine
antimalarial ACT
Also known as: Euratesim, Sigma-Tau
antimalarial ACT
Also known as: Coartem, Novartis
Adequate clinical and parasitological response
Absence of parasitaemia on day 42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
Time frame: 42 days after treatement start
Early treatment failure
* General danger signs or signs of severe malaria on days 1, 2, or 3, in the presence of parasitaemia , or * Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature, or * Parasitaemia on day 3 with axillary temperature ≥ 37.5°C, or * Parasitaemia on day 3 ≥ 25% count on day 0 irrespective of axillary temperature.
Time frame: 1 to 3 days after tratment start
Late clinical failure
* General danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 42 in patients who did not previously meet any of the criteria of early treatment failure; or * Presence of parasitaemia on any day between day 4 and day 42 with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure.
Time frame: from day 4 to day 42 after treatment start
Late Parasitological Failure
- Presence of parasitaemia on any day between day 7 and day 42 with axillary temperature \< 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.
Time frame: from day 7 to day 42 after treatment start
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Artesunate · Amodiaquine · Artenimol · Piperaquine
Epicentre