Uncomplicated MalariaTES2016NCT03387631
Efficacy And Safety Of AL For The Treatment Of Uncomplicated Falciparum Malaria In Mainland Tanzania
An observational study of Uncomplicated Malaria, run by National Institute for Medical Research, Tanzania.
Trial summary
Following the development of drug resistance to antimalarial first line treatment of uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health - Tanzania, introduced ACTs with AL as first line treatment for uncomplicated falciparum malaria in 2006. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Uncomplicated Malaria
- What is being tested?
- Artemether-Lumefantrine
- How many people
- 344 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 2016
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients aged 6 months-10 years and with uncomplicated falciparum malaria presenting at the study health clinics. Parents or guardians will give informed consent on behalf of their children.
Who may be able to join
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia of 250 - 200,000/μl asexual forms;
- presence of axillary temperature ≥37.5 °C or history of fever during the past 24 hours
- ability to swallow oral medication;
- ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
- Informed consent from the parents or guardians of children.
Who cannot join
- presence of general danger signs in children aged 6 months-10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
- weight under 5 Kg
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s
About this study
Official title: Efficacy and Safety of Artemether Lumefantrine for the Treatment of Uncomplicated Malaria in Tanzania
Following the development of drug resistance to antimalarial first line treatment of uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health - Tanzania, introduced ACTs with AL as first line treatment for uncomplicated falciparum malaria in 2006. In the advent of wide scale deployment of ACT together with strengthened vector control with LLIN in mainland Tanzania, there is a trend of shrinking the burden of malaria. The decline of outpatient malaria cases in recent years and declining entomological inoculation rates (EIR) that are currently being recorded in most areas that were before considered to be holo/hyper-endemic to malaria transmission is another indicator of the shift in the epidemiology of malaria transmission in Tanzania. This current shift provides a new and yet critical challenge with regards to assessment and monitoring of the efficacy of the first-line treatment specifically considering that artemisinin resistance has been confirmed in the Greater Mekong sub-region. The aim of the study was to set up a system for country wide representative surveillance to obtain data of the safety and efficacy of AL following countrywide use of ACTs for treatment of uncomplicated malaria in Tanzania. The study was conducted in the framework of the existing NMCP sentinel sites that are ecological representative for malaria endemicity in Tanzania Objective: To assess the efficacy and safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Tanzania.
Methods: The study was conducted in eight sentinel sites of NMCP (Kyela, Mkuzi, Kibaha, Ujiji, Nagaga, Chamwino, Igombe and Mlimba) in mainland Tanzania. Four sentinel sites (Mlimba, Mkuzi, Kibaha, and Ujiji) were covered in 2016 and the rest will be involved in the second round to be undertaken in 2017.
Patients were treated with AL for 3 days and the study was conducted from April to Sept 2016. The results of this study will assist the Ministry of Health to monitor the efficacy and safety of the ACTs in Tanzania, provide baseline data on parasite clearance time and for assessing the current national treatment guidelines for uncomplicated falciparum malaria.
Read the detailed description
The study was on safety and efficacy of artemether lumefantrine for the treatment of uncomplicated malaria, to be done in 8 National Malaria Control Programme sentinel sites The study was proposed to be done in 2 phases; the first phase in Mkuzi, Ujiji, Kibaha and Mlimba fro April 2016-Sept 2016 The second phase to be done in the other 4 sites of Igombe, Chwamwino, Kyela and Nagaga from February - October 2017
- Conditions
- Uncomplicated Malaria
- Being tested
- Artemether-Lumefantrine
- Keywords
- Efficacy safety uncomplicated malaria AL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-LumefantrineDrug
Also called Coartem
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rates as per WHO protocol
number with ACPR
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 344 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Celine Mandara, National Institute for Medical Research, Tanzania
- Investigators
- Deusdedith S Ishengoma, PhD, Principal investigator, National Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387631
- Sponsor's protocol ID
- NIMRTanzania
- Acronym
- TES2016
- Status last verified
- Feb 2017
- First submitted
- 21 Feb 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ishengoma DS, Mandara CI, Francis F, Talundzic E, Lucchi NW, Ngasala B, Kabanywanyi AM, Mahende MK, Kamugisha E, Kavishe RA, Muro F, Mohamed A, Mandike R, Mkude S, Chacky F, Paxton L, Greer G, Kitojo CA, Njau R, Martin T, Venkatesan M, Warsame M, Halsey ES, Udhayakumar V. Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated malaria and prevalence of Pfk13 and Pfmdr1 polymorphisms after a decade of using artemisinin-based combination therapy in mainland Tanzania. Malar J. 2019 Mar 21;18(1):88. doi: 10.1186/s12936-019-2730-1.
PubMed 30898164
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Artemether Lumefantrine for the Treatment of Uncomplicated Malaria in Tanzania
- ClinicalTrials.gov ID
- NCT03387631
- Acronym / sponsor ID
- TES2016 / NIMRTanzania
- Conditions
- Uncomplicated Malaria
- Keywords
- Efficacy safety uncomplicated malaria AL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following the development of drug resistance to antimalarial first line treatment of uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health - Tanzania, introduced ACTs with AL as first line treatment for uncomplicated falciparum malaria in 2006. In the advent of wide scale deployment of ACT together with strengthened vector control with LLIN in mainland Tanzania, there is a trend of shrinking the burden of malaria. The decline of outpatient malaria cases in recent years and declining entomological inoculation rates (EIR) that are currently being recorded in most areas that were before considered to be holo/hyper-endemic to malaria transmission is another indicator of the shift in the epidemiology of malaria transmission in Tanzania. This current shift provides a new and yet critical challenge with regards to assessment and monitoring of the efficacy of the first-line treatment specifically considering that artemisinin resistance has been confirmed in the Greater Mekong sub-region. The aim of the study was to set up a system for country wide representative surveillance to obtain data of the safety and efficacy of AL following countrywide use of ACTs for treatment of uncomplicated malaria in Tanzania. The study was conducted in the framework of the existing NMCP sentinel sites that are ecological representative for malaria endemicity in Tanzania Objective: To assess the efficacy and safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Tanzania.
Methods: The study was conducted in eight sentinel sites of NMCP (Kyela, Mkuzi, Kibaha, Ujiji, Nagaga, Chamwino, Igombe and Mlimba) in mainland Tanzania. Four sentinel sites (Mlimba, Mkuzi, Kibaha, and Ujiji) were covered in 2016 and the rest will be involved in the second round to be undertaken in 2017.
Patients were treated with AL for 3 days and the study was conducted from April to Sept 2016. The results of this study will assist the Ministry of Health to monitor the efficacy and safety of the ACTs in Tanzania, provide baseline data on parasite clearance time and for assessing the current national treatment guidelines for uncomplicated falciparum malaria.
Detailed description
The study was on safety and efficacy of artemether lumefantrine for the treatment of uncomplicated malaria, to be done in 8 National Malaria Control Programme sentinel sites The study was proposed to be done in 2 phases; the first phase in Mkuzi, Ujiji, Kibaha and Mlimba fro April 2016-Sept 2016 The second phase to be done in the other 4 sites of Igombe, Chwamwino, Kyela and Nagaga from February - October 2017
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients aged 6 months-10 years and with uncomplicated falciparum malaria presenting at the study health clinics. Parents or guardians will give informed consent on behalf of their children.
Key inclusion criteria (6 listed)
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia of 250 - 200,000/μl asexual forms;
- presence of axillary temperature ≥37.5 °C or history of fever during the past 24 hours
- ability to swallow oral medication;
- ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
Key exclusion criteria (7 listed)
- presence of general danger signs in children aged 6 months-10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
- weight under 5 Kg
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-LumefantrineAlso: Coartem | Drug | – |
Primary outcome
Cure rates as per WHO protocol
Time frame: 28 days
number with ACPR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Derived from this study: PubMed 30898164Ishengoma DS, Mandara CI, Francis F, Talundzic E, Lucchi NW, Ngasala B, Kabanywanyi AM, Mahende MK, Kamugisha E, Kavishe RA, Muro F, Mohamed A, Mandike R, Mkude S, Chacky F, Paxton L, Greer G, Kitojo CA, Njau R, Martin T, Venkatesan M, Warsame M, Halsey ES, Udhayakumar V. Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated malaria and prevalence of Pfk13 and Pfmdr1 polymorphisms after a decade of using artemisinin-based combination therapy in mainland Tanzania. Malar J. 2019 Mar 21;18(1):88. doi: 10.1186/s12936-019-2730-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deusdedith S Ishengoma, PhD principal investigator
National Institute for Medical Research
Questions about this trial
What is this clinical trial studying?
An observational study of Uncomplicated Malaria, run by National Institute for Medical Research, Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rates as per WHO protocol (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.