Uncomplicated Falciparum MalariaPhase 4GF-TES-2017NCT03431714
Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
A Phase 4 study testing Artesunate amodiaquine in people with Uncomplicated Falciparum Malaria, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
Trial summary
The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of… Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Uncomplicated Falciparum Malaria
- What is being tested?
- Artesunate amodiaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteTanzania
- Study dates
- 14 Jul 2017to 8 Dec 2017
- Phase
- Phase 4
- 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
Who may be able to join
- Patients aged 6 months to 10 years.
- 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
- mRDT negative
- presence of general danger signs in children aged 6 months to 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 in children ≤ 59 months; or BMI of <16 in children aged 5 years and above)
- 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of different antimalarials in the country. Most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data on the performance of other artemisinin based combination therapy (ACTs) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. This study was undertaken in the same NMCP framework to assess the efficacy and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP sentinel sites of Kibaha and Ujiji from July to December 2017.
- Conditions
- Uncomplicated Falciparum Malaria
- Being tested
- Artesunate amodiaquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate amodiaquineDrug
Also called dihydroartemisinin piperaquine
Drugs were administered under observation of the study nurse for three days
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Artesunate amodiaquine tablets containing 25/67.5 mg, 50/135mg and 100/270 mg base of artesunate-amodiaquine were administered according to body weight Dihrdroartemisinin piperaquine tablets containing 160/20mg and 320/40mg base of piperaquine dihydroartemisinin were administered according to body weight Receives: Drug: Artesunate amodiaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate clinical response
Proportions of patients with 100% cure before PCR correction
Measured: 28 days
Secondary outcomes (1)
PCR corrected responses
Proportions of patients with 100% cure after PCR correction
Measured: one months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start14 Jul 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
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 Falciparum 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The first group of 88 children were recruited first and given dihydroartemisinin- piperaquine, once the sample size was attained, the second group for artesunate amodiaquine followed and the follow-up for the two groups were running concurrently
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Collaborators
- Muhimbili University of Health and Allied Sciences, World Health Organization
- Responsible party
- Principal investigator, Dr. Celine Mandara, National Institute for Medical Research, Tanzania
- Investigators
- Deus S Ishengoma, PhD, Principal investigator, National Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431714
- Sponsor's protocol ID
- NIMR-Tanzania
- Acronym
- GF-TES-2017
- Status last verified
- Feb 2018
- First submitted
- 22 Dec 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mandara CI, Francis F, Chiduo MG, Ngasala B, Mandike R, Mkude S, Chacky F, Molteni F, Njau R, Mohamed A, Warsame M, Ishengoma DS. High cure rates and tolerability of artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Kibaha and Kigoma, Tanzania. Malar J. 2019 Mar 25;18(1):99. doi: 10.1186/s12936-019-2740-z.
PubMed 30909922
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
- ClinicalTrials.gov ID
- NCT03431714
- Acronym / sponsor ID
- GF-TES-2017 / NIMR-Tanzania
- Conditions
- Uncomplicated Falciparum Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Collaborators
- Muhimbili University of Health and Allied Sciences, World Health Organization
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 13 Feb 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.
The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of different antimalarials in the country. Most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data on the performance of other artemisinin based combination therapy (ACTs) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. This study was undertaken in the same NMCP framework to assess the efficacy and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP sentinel sites of Kibaha and Ujiji from July to December 2017.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The first group of 88 children were recruited first and given dihydroartemisinin- piperaquine, once the sample size was attained, the second group for artesunate amodiaquine followed and the follow-up for the two groups were running concurrently
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Artesunate amodiaquineArtesunate amodiaquine tablets containing 25/67.5 mg, 50/135mg and 100/270 mg base of artesunate-amodiaquine were administered according to body weight Dihrdroartemisinin piperaquine tablets containing 160/20mg and 320/40mg base of piperaquine dihydroartemisinin were administered according to body weight |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients aged 6 months to 10 years.
- 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;
Key exclusion criteria (8 listed)
- mRDT negative
- presence of general danger signs in children aged 6 months to 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 in children ≤ 59 months; or BMI of <16 in children aged 5 years and above)
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 |
|---|---|---|
| Artesunate amodiaquineAlso: dihydroartemisinin piperaquineDrugs were administered under observation of the study nurse for three days | Drug | single arm |
Primary outcome
Adequate clinical response
Time frame: 28 days
Proportions of patients with 100% cure before PCR correction
1 secondary outcome
PCR corrected responses
Time frame: one months after study completion
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 13 Feb 2018.
- Derived from this study: PubMed 30909922Mandara CI, Francis F, Chiduo MG, Ngasala B, Mandike R, Mkude S, Chacky F, Molteni F, Njau R, Mohamed A, Warsame M, Ishengoma DS. High cure rates and tolerability of artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Kibaha and Kigoma, Tanzania. Malar J. 2019 Mar 25;18(1):99. doi: 10.1186/s12936-019-2740-z.
- 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.
Deus S Ishengoma, PhD principal investigator
National Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artesunate amodiaquine in people with Uncomplicated Falciparum Malaria, run by National Institute for Medical Research, Tanzania at 1 site in 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 7 inclusion and 8 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adequate clinical response (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 NCT03431714, 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 13 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.