MalariaNCT06472258
Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study
A study testing IV Artesunate and IV Quinine Hydrochloride in people with Malaria, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
The WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Malaria
- What is being tested?
- IV Artesunate and IV Quinine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 30 Jun 2023
- Phase
- Interventional
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children admitted to the emergency department with the diagnosis of severe malaria.
Who cannot join
- Children with chronic kidney disease, chronic liver disease, immunosuppressive disorders, hematological disorders, malignancies, and congenital heart disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, 32200
About this study
The WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Therefore, this research intended to evaluate the efficacy of only IV artesunate versus IV artesunate plus IV quinine in the treatment of severe malaria in children. The findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.
- Conditions
- Malaria
- Being tested
- IV Artesunate, IV Quinine Hydrochloride
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ArtesunateDrug
Also called Artesunate
IV artesunate with a weight-appropriate dosage at 0, 12, 24, and 48 hours and continued 12-hourly for a maximum duration of seven days, with each dose diluted in normal saline and given as an infusion.
IV Quinine HydrochlorideDrug
Also called Artesunate plus IV Quinine Hydrochloride
IV Quinine hydrochloride in accordance to weight with loading dose 20mg salt/kg in 10% dextrose infusion followed by 10mg salt/kg infusion 8 hourly for 2 days and for 12 hourly onwards for a maximum of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| IV Artesunate Group | Experimental | IV Artesunate with weight appropriate dosage on 0, 12, 24 and 48 hours, and continued 12 hourly for a maximum duration of seven days. Each dose diluted in normal saline given as infusion. Receives: Drug: IV Artesunate |
| Combination Group | Experimental | IV Artesunate with weight appropriate dose on 0, 12, 24 and 48 hours, plus IV Quinine hydrochloride in accordance to weight with loading dose 20mg salt/kg in 10% dextrose infusion followed by 10mg salt/kg infusion 8 hourly for 2 days and for 12 hourly onwards for a maximum of 7 days. Receives: Drug: IV Artesunate; Drug: IV Quinine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride
The outcome was measured in the number of hours elapsed for an individual to become fever-free.
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Mar 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472258
- Sponsor's protocol ID
- DGKhan
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be shared on a reasonable request made to primary investigators.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study
- ClinicalTrials.gov ID
- NCT06472258
- Acronym / sponsor ID
- DGKhan
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Jun 2024 (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 WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Therefore, this research intended to evaluate the efficacy of only IV artesunate versus IV artesunate plus IV quinine in the treatment of severe malaria in children. The findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Artesunate Group | Experimental | Drug: IV ArtesunateIV Artesunate with weight appropriate dosage on 0, 12, 24 and 48 hours, and continued 12 hourly for a maximum duration of seven days. Each dose diluted in normal saline given as infusion. |
| Combination Group | Experimental | Drug: IV Artesunate, Drug: IV Quinine HydrochlorideIV Artesunate with weight appropriate dose on 0, 12, 24 and 48 hours, plus IV Quinine hydrochloride in accordance to weight with loading dose 20mg salt/kg in 10% dextrose infusion followed by 10mg salt/kg infusion 8 hourly for 2 days and for 12 hourly onwards for a maximum of 7 days. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children admitted to the emergency department with the diagnosis of severe malaria.
Key exclusion criteria (1 listed)
- Children with chronic kidney disease, chronic liver disease, immunosuppressive disorders, hematological disorders, malignancies, and congenital heart disease.
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 |
|---|---|---|
| IV ArtesunateAlso: ArtesunateIV artesunate with a weight-appropriate dosage at 0, 12, 24, and 48 hours and continued 12-hourly for a maximum duration of seven days, with each dose diluted in normal saline and given as an infusion. | Drug | Combination Group, IV Artesunate Group |
| IV Quinine HydrochlorideAlso: Artesunate plus IV Quinine HydrochlorideIV Quinine hydrochloride in accordance to weight with loading dose 20mg salt/kg in 10% dextrose infusion followed by 10mg salt/kg infusion 8 hourly for 2 days and for 12 hourly onwards for a maximum of 7 days. | Drug | Combination Group |
Primary outcome
Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride
Time frame: Seven days
The outcome was measured in the number of hours elapsed for an individual to become fever-free.
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 26 Jun 2024.
- Individual participant dataSharing planned: No. It can be shared on a reasonable request made to primary investigators.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV Artesunate and IV Quinine Hydrochloride in people with Malaria, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 1 inclusion and 1 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 26 Jun 2024. 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 Pakistan. 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.
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?
Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride (time frame: Seven days). 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 26 Jun 2024.