MalariaPhase 4NCT07713602
Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
A Phase 4 study testing Coartem® Baby in people with Malaria, run by Novartis Pharmaceuticals.
Trial summary
This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to <5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions. Read more about this study
- Who is it for?
- Ages 0 days to 12 months
- Conditions the study is for
- Malaria
- What is being tested?
- Coartem® Baby
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 18 Jun 2027to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 0 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female neonates/infants
- Body weight ≥ 2 kg to < 5kg
- Confirmed diagnosis of uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum malaria by RDT or microscopy.
- Eligible to receive Coartem® Baby dispersible tablets as per approved label
Who cannot join
- Participants with Coartem® Baby contraindications as per approved label.
- Known hypersensitivity to artemether, lumefantrine or to any of the excipients of Coartem® Baby.
- Patients with severe malaria according to WHO definition (See Appendix 3).
- Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
- Patients taking drugs that are known to prolong the QTc interval
- Any additional contraindications as per the approved label in the country
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: A Multi-centre, Open-label, Non-comparative Study to Assess Safety and Clinical Response With Coartem® Baby Dispersible Tablets in Paediatric Patients (≥ 2 to <5 kg) With Uncomplicated Malaria Due to Plasmodium Falciparum or Mixed Infections
This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to <5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.
Read the detailed description
This is a multi-center, open-label, non-comparative study in neonates and infants (2 to < 5 kg) diagnosed with acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum malaria. The study is being performed in response to requests from Swissmedic and African National Regulatory Authorities following the approval of Coartem® Baby, to generate additional post-marketing data in this patient population.
- Conditions
- Malaria
- Being tested
- Coartem® Baby
- Keywords
- Safety, clinical outcome, Coartem® Baby, infant, neonates, body weight ≥ 2 to <5 kg, uncomplicated malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coartem® BabyDrug
Also called Artemether: Lumefantrine
Coartem® Baby 2.5mg/30mg oral dispersible tablets to be used at dose of 5mg/60 mg twice per day for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Coartem® Baby (5mg/60mg) | Experimental | Participants will receive Coartem® Baby at dose of 5mg/60mg twice per day for 3 days. Receives: Drug: Coartem® Baby |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
Measured: Up to Day 29
Secondary outcomes (2)
Proportion of patients with no malaria symptoms
Clinical response is defined as - No malaria symptoms such as (and not limited to) fever, chills, poor feeding, respiratory distress, irritability or restlessness as evaluated by the treating physician.
Measured: From Day 7 to Day 29
Proportion of patients with positive parasitaemia
Positive parasitaemia is defined as at least ≥100 parasites/µl by microscopy during follow up visits in presence of recurrence/persistence/worsening of malaria symptoms.
Measured: From Day 7 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start18 Jun 2027 (estimated)
- Primary completion4 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713602
- Sponsor's protocol ID
- CCOA566B2405
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open-label, Non-comparative Study to Assess Safety and Clinical Response With Coartem® Baby Dispersible Tablets in Paediatric Patients (≥ 2 to <5 kg) With Uncomplicated Malaria Due to Plasmodium Falciparum or Mixed Infections
- ClinicalTrials.gov ID
- NCT07713602
- Acronym / sponsor ID
- CCOA566B2405
- Conditions
- Malaria
- Keywords
- Safety, clinical outcome, Coartem® Baby, infant, neonates, body weight ≥ 2 to <5 kg, uncomplicated malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2027 (estimated)
- Primary completion
- 4 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 Jul 2026 (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.
This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to <5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.
Detailed description
This is a multi-center, open-label, non-comparative study in neonates and infants (2 to < 5 kg) diagnosed with acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum malaria. The study is being performed in response to requests from Swissmedic and African National Regulatory Authorities following the approval of Coartem® Baby, to generate additional post-marketing data in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coartem® Baby (5mg/60mg) | Experimental | Drug: Coartem® BabyParticipants will receive Coartem® Baby at dose of 5mg/60mg twice per day for 3 days. |
Who may qualify
- Ages
- 0 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female neonates/infants
- Body weight ≥ 2 kg to < 5kg
- Confirmed diagnosis of uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum malaria by RDT or microscopy.
- Eligible to receive Coartem® Baby dispersible tablets as per approved label
Key exclusion criteria (6 listed)
- Participants with Coartem® Baby contraindications as per approved label.
- Known hypersensitivity to artemether, lumefantrine or to any of the excipients of Coartem® Baby.
- Patients with severe malaria according to WHO definition (See Appendix 3).
- Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
- Patients taking drugs that are known to prolong the QTc interval
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 |
|---|---|---|
| Coartem® BabyAlso: Artemether: LumefantrineCoartem® Baby 2.5mg/30mg oral dispersible tablets to be used at dose of 5mg/60 mg twice per day for 3 days. | Drug | Coartem® Baby (5mg/60mg) |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 29
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
2 secondary outcomes
Proportion of patients with no malaria symptoms
Time frame: From Day 7 to Day 29
Proportion of patients with positive parasitaemia
Time frame: From Day 7 to Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coartem® Baby in people with Malaria, run by Novartis Pharmaceuticals.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Jul 2026. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.