Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508856741773 Date of Registration: 08/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Djibouti in-vivo therapeutic efficacy study -2024
Official scientific title Efficacy and Safety of Artemether-Lumefantrine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Health Facilities in Djibouti City, Republic of Djibouti
Brief summary describing the background and objectives of the trial The evidence of resistance to chloroquine and the widespread resistance in Djibouti and the sub-region1 countries directed WHO to recommend the use of therapeutic combinations based on artemisinin derivatives (ACT) in 2006. The country adopted the combination Artesunate + Sulfadoxine-Pyrimethamine (AS+SP) instead of chloroquine for the first-line treatment of uncomplicated malaria and Artemether + Lumefantrine (AL) as a second-line drug. The revision of the treatment protocol in 2014 led to the adoption of Artemether-Lumefantrine (AL) in the first-line, and Artesunate Amodiaquine (As+ AQ) in the second-line. These medicines, like all malaria treatments in the Republic of Djibouti, are free of charge. However, the WHO recommends that the introduction of a new therapy in a country, including artemisinin, be preceded by a study to determine the basic efficacy of the new treatment, which was not done in Djibouti. The National Malaria Control Program of Djibouti proposes to conduct a first study on the effectiveness of artemether-lumefantrine, according to the WHO protocol. The aim of this study is to evaluate the therapeutic efficacy and safety of AL for the treatment of noncomplicated P.falciparum malaria in the Arhiba Polyclinic in Djibouti. The results of this study will enable the Ministry of Health of the Republic of Djibouti to assess the current national policy for the treatment of uncomplicated P. falciparum malaria and to make an informed decision on whether it should be updated.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) TES
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/03/2024
Actual trial start date 30/03/2024
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 88
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artemetherlumefantrine Fixed-dose tablets containing 20 mg of artemether plus 120 mg of lumefantrine twice daily For three days Artemether-lumefantrine (Coartem; Novartis) is the first-line antimalarial drug used to treat falciparum malaria in Djibouti 88
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age between six months and older 2. Monospecific infestation with P. falciparum detected by microscopic examination parasitemia between 500 and 200,000/μl (asexual parasite forms) 3. Axillary temperature ≥37.5°C or history of fever in the last 24 hours; ability to take oral medications 4. Ability and willingness to adhere to the protocol for the duration of the study and to respect the consultation schedule 5. Informed consent of the patient, or the parent or guardian, in the case of children under the age of majority in that country and informed consent of all minor participants over the age of twelve and under the age of majority in that country 1. Presence of general danger signs in children under 12 years of age or signs of severe P. falciparum malaria as defined by WHO. 2. Body weight less than 5 kg; 3. Hemoglobin < 8 g/dl; mixed or monospecific infestation with another species of Plasmodium, detected by microscopic examination 4. Severe malnutrition defined as a child aged 6-60 months with a mid-upper arm circumference <115 mm) 5. Febrile illness due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, a severe diarrheal disease with dehydration) or other known chronic or serious underlying diseases (e.g. heart, kidney or liver disease, HIV/AIDS); 6. Regular use of medication, which may interfere with the pharmacokinetics of the antimalarial drug; history of hypersensitivity to, or contraindication to, any of the drugs tested or used as an alternative therapy 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 6 Month(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/03/2024 Djibouti minister of health ethics commitee
Ethics Committee Address
Street address City Postal code Country
route de la siesta Djibouti 1974 Djibouti
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adequate clinical and parasitological response Day 28
Secondary Outcome 1. To differentiate between recrudescence and new infection using polymerase chain reaction (PCR) analysis. 2. To assess the incidence of adverse events. 3. To determine the polymorphism of artemisinin resistance molecular markers. During the follow up days 0, 1, 2, 3, 7, 14, 21, and 28.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Arhiba Arhiba Djibouti Djibouti
Ali Sabieh Ali-Sabieh Ali Sabieh Djibouti
Tadjourah regional Hospital Tadjourah Tadjourah Djibouti
FUNDING SOURCES
Name of source Street address City Postal code Country
Armauer Hansen Research Institute AHRI Jimma Road, ALERT Compound Addis Ababa 1005 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Armauer Hansen Research Institute Jimma Road, ALERT Compound Addis Ababa 1005 Ethiopia Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Armauer Hansen Research Institute AHRI Jimma Road, ALERT Compound Addis Ababa 1005 Ethiopia
Ministry of Health Ethiopia 1234 Sudan Street Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bouh Abdi Khaireh bouh.abdi@associationmutualis.org 25377068525 Avenue George Clemenceau, Djibouti
City Postal code Country Position/Affiliation
Djibouti Djibouti Malaria response Head
Role Name Email Phone Street address
Public Enquiries Fitsum Tadesse fitsum.girma@ahri.gov.et +251912627540 Achalu Street
City Postal code Country Position/Affiliation
Addis Ababa 1005 Ethiopia Lead Scientist at Armauer Hansen Research Institute
Role Name Email Phone Street address
Scientific Enquiries Samatar Kayad Guelleh samatark24@gmail.com +25377705311 Avenue George Clemenceau Djibouti
City Postal code Country Position/Affiliation
Djibouti Djibouti Co investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual clinical trial participant-level data including demographic data, and clinical and parasitological evaluation data will be shared to the Ministry of health Djibouti policymakers, collaborating institutions and researchers for further analyses and decision-making. The dataset will be shared via the publication. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol End of the study Study findings and supplementary data will be accessed via publications , workshops and seminars
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 02/07/2025 updated based on comments The evidence of resistance to chloroquine and the widespread resistance in Djibouti and the sub-region1 countries directed WHO to recommend the use of therapeutic combinations based on artemisinin derivatives (ACT) in 2006. The country adopted the combination Artesunate + Sulfadoxine-Pyrimethamine (AS+SP) instead of chloroquine for the first-line treatment of uncomplicated malaria and Artemether + Lumefantrine (AL) as a second-line drug. The revision of the treatment protocol in 2014 led to the adoption of Artemether-Lumefantrine (AL) in the first-line, and Artesunate Amodiaquine (As+ AQ) in the second-line. These medicines, like all malaria treatments in the Republic of Djibouti, are free of charge. However, the WHO recommends that the introduction of a new therapy in a country, including artemisinin, be preceded by a study to determine the basic efficacy of the new treatment, which was not done in Djibouti. The administration of AL, especially in children, is accompanied by several adverse effects. Falade described Nigerian children's cough, anemia, vomiting, anoxia, diarrhea, hepatomegaly, splenomegaly, and upper respiratory tract infection. For his part, Adjeia describes dizziness, fatigue, excessive drowsiness, itching, vomiting, and nausea in Ghanaian children. Finally, Faye reported on Ivorian and Senegalese children's asthenia (body weakness), anorexia, vomiting, sputum, diarrhea, abdominal pain, and nausea. All these manifestations are usually moderate and disappear at the end of treatment. The National Malaria Control Program of Djibouti proposes to conduct a first study on the effectiveness of artemether-lumefantrine, according to the WHO protocol. The results of this study will enable the Ministry of Health of the Republic of Djibouti to assess the current national policy for the treatment of uncomplicated P. falciparum malaria and to make an informed decision on whether it should be updated. The evidence of resistance to chloroquine and the widespread resistance in Djibouti and the sub-region1 countries directed WHO to recommend the use of therapeutic combinations based on artemisinin derivatives (ACT) in 2006. The country adopted the combination Artesunate + Sulfadoxine-Pyrimethamine (AS+SP) instead of chloroquine for the first-line treatment of uncomplicated malaria and Artemether + Lumefantrine (AL) as a second-line drug. The revision of the treatment protocol in 2014 led to the adoption of Artemether-Lumefantrine (AL) in the first-line, and Artesunate Amodiaquine (As+ AQ) in the second-line. These medicines, like all malaria treatments in the Republic of Djibouti, are free of charge. However, the WHO recommends that the introduction of a new therapy in a country, including artemisinin, be preceded by a study to determine the basic efficacy of the new treatment, which was not done in Djibouti. The National Malaria Control Program of Djibouti proposes to conduct a first study on the effectiveness of artemether-lumefantrine, according to the WHO protocol. The aim of this study is to evaluate the therapeutic efficacy and safety of AL for the treatment of noncomplicated P.falciparum malaria in the Arhiba Polyclinic in Djibouti. The results of this study will enable the Ministry of Health of the Republic of Djibouti to assess the current national policy for the treatment of uncomplicated P. falciparum malaria and to make an informed decision on whether it should be updated.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 08/08/2025 PACTR Admin 30 Mar 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 02/07/2025 the study conducted in a single site 2112 88
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 04/07/2025 The Recruitment Status is completed Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/07/2025 the study is conducted in a single site Experimental Group, Artemetherlumefantrine, Fixed-dose tablets containing 20 mg of artemether plus 120 mg of lumefantrine twice daily, For three days, Artemether-lumefantrine (Coartem; Novartis) is the first-line antimalarial drug used to treat falciparum malaria in Djibouti, 264, Experimental Group, Artemetherlumefantrine, Fixed-dose tablets containing 20 mg of artemether plus 120 mg of lumefantrine twice daily, For three days, Artemether-lumefantrine (Coartem; Novartis) is the first-line antimalarial drug used to treat falciparum malaria in Djibouti, 88,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 02/07/2025 Clarifying the time point for outcome measure Primary Outcome, To measure the clinical and parasitological effectiveness of artemether-lumefantrine , Day 28 Primary Outcome, To measure the clinical and parasitological effectiveness of artemether-lumefantrine , The primary outcome will be measured on Day 28.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/07/2025 Clarifying the time point for outcome measure Primary Outcome, To measure the clinical and parasitological effectiveness of artemether-lumefantrine , The primary outcome will be measured on Day 28. Primary Outcome, To measure the clinical and parasitological effectiveness of artemether-lumefantrine , Day 28
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/07/2025 Clarifying the time point for outcome measure Primary Outcome, To measure the clinical and parasitological effectiveness of artemether-lumefantrine , Day 28 Primary Outcome, Adequate clinical and parasitological response , Day 28
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 02/07/2025 Clarifying the time points for outcome measurement. Secondary Outcome, 1. To differentiate between recrudescence and new infection using polymerase chain reaction (PCR) analysis. 2. To assess the incidence of adverse events. 3. To determine the polymorphism of artemisinin resistance molecular markers., On days 0, 1, 2, 3, 7, 14, 21, and 28 Secondary Outcome, 1. To differentiate between recrudescence and new infection using polymerase chain reaction (PCR) analysis. 2. To assess the incidence of adverse events. 3. To determine the polymorphism of artemisinin resistance molecular markers., The secondary outcomes will be measured during the follow up on days 0, 1, 2, 3, 7, 14, 21, and 28.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/07/2025 Clarifying the time points for outcome measurement. Secondary Outcome, 1. To differentiate between recrudescence and new infection using polymerase chain reaction (PCR) analysis. 2. To assess the incidence of adverse events. 3. To determine the polymorphism of artemisinin resistance molecular markers., The secondary outcomes will be measured during the follow up on days 0, 1, 2, 3, 7, 14, 21, and 28. Secondary Outcome, 1. To differentiate between recrudescence and new infection using polymerase chain reaction (PCR) analysis. 2. To assess the incidence of adverse events. 3. To determine the polymorphism of artemisinin resistance molecular markers., During the follow up days 0, 1, 2, 3, 7, 14, 21, and 28.