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1. Therapeutic efficacy and safety of AL for
Treating Uncomplicated Plasmodium
falciparum Malaria in Djibouti's Health
Facilities
Tirhas Endale

2. CONTENTS
● Background
● Objective
● Methodology
● Eligibility
● Lost follow up scenarios
● Protocol withdrawal and violations
● Treatment
● Microscopy
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3. BACKGROUND
● The resistance of Pf to chloroquine in Djibouti and many endemic
countries adopted the use of artemisinin based combinations .
● Djibouti adopted the combination (AS+SP) as the first-line
treatment for uncomplicated malaria.
● Later switched to AL as the first-line treatment in 2014,
 with Artesunate Amodiaquine (AS+AQ) as the second-line treatment.
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4. OBJECTIVE
● Main objective - Measure effectiveness of AL in patients aged > 6
months with uncomplicated Pf.
● Secondary objectives include
● Differentiating between reinfection and new infection using
PCR analysis,
● Assessing adverse events
● Determining the polymorphism of artemisinin resistance
molecular markers.
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3/27/2024 Efficacy and Saftey of AL in Selected HC in Dijiboti - Tirhas Endale

5. METHODOLOGY
● One-arm prospective cohort study
● Patients - monitored for 28 days.
● Responses- therapeutic failure (early or late) or adequate
response.
● The efficacy of AL - proportion of patients with therapeutic
failure during follow-up.
● PCR analysis will be used to differentiate between therapeutic
failure and re-exposure.
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3/27/2024 Efficacy and Saftey of AL in Selected HC in Dijiboti - Tirhas Endale

6. Cont…
●Study population – 6 months and above
●The study requires a minimum of 73 patients.
●Considering lost to follow ups, 88 patients at the study site needed.
●Therapeutic failure rate of AL is estimated to be 5%.
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7. ELIGIBILTY
Inclusion criteria
●age > 6 months;
●monospecific infestation by P. falciparum by microscopy.
Exclusion criteria
●General danger signs in children < 12 years of age.
●Signs of severe P.f.
●Weight < 5 kg
●Hemoglobin < 8g/dl
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8. LOST to
FOLLOW UP
● Does not attend scheduled consultations and cannot be located,
they are considered lost to follow-up.
● No therapeutic outcome is assigned to them, and efforts should
be made to schedule a follow-up visit, especially during the drug
administration period.
● These lost to follow-up patients will be classified as such, and
their data will be censored or excluded from the analysis.
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9. PROTOCOL
● Withdraw their consent.
● Persistent vomiting after taking the medication twice.
● Fail to attend scheduled consultations within the first three
days
● Have serious adverse events requiring treatment termination.
● Severe malaria within 24 hours of starting treatment is
another reason for withdrawal.
● Illnesses hindering treatment evaluation
● Detection of a different type of malaria during monitoring, or
misclassification due to a laboratory error.
INTERUPTION
WITHDRAWAL
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10. MICROSCOPY
● Thick blood smears will be collected.
● Stained with Geimsa.
● Three blood smears per patient will be prepared.
● Additional smears will be analyzed if the initial count is inconclusive.
● Gametocytes will also be detected and counted. Confirmation of mixed
infestations may be done if needed.
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11. TREATMENT
PROTOCOL
● Patients are observed for 30 minutes after administration
● If vomiting occurs, they receive another dose and continue
to be observed.
● PCM can be used to treat a fever > 38°C.
● If non-malaria infections require antimalarial drugs, patients
will be withdrawn.
● Self-medication or taking antimalarials or antibiotics will
result in withdrawal.
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12. Early treatment failure (ETF)
● Severe malaria on days 1, 2, or 3 in the presence of parasitemia.
Late clinical failure (LCF)
● Danger signs for severe malaria after day 3 in the presence of
parasitemia, without ETF.
Late parasitological failure (LPF)
● Parasitemia on any day from day 7 to day 28 and Temp <37.5°C,
without ETF or LCF.
Adequate Clinical and Parasitological Response (ACPR)
● Absence of parasitemia on day 28 without any of ETF, LTF, or LPF.
RESPONSE TO Rx
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