MalariaPhase 4IVASNCT01805232
Intravenous Artesunate and Malaria
A Phase 4 study testing artesunate and Quinine in people with Malaria, run by University of Khartoum at 1 site in Sudan.
Trial summary
Intravenous artesunate is egual to quinine in the treatment of severe malaria Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Malaria
- What is being tested?
- artesunate and Quinine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSudan
- Study dates
- Mar 2013to Jul 2013
- 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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- severe P.falciparum malaria-
Who cannot join
- mixed infection Pregnant women -
Trial locations and contacts
1 site in 1 country.
Sudan1 site, 1 recruiting
- Recruiting
Kassala
Kassala, Kassala, 249
Abzinab A Ali, MD, +249911259199 ext. 122, ishagadamm@yahoo.com
Tajeldien A Abdulla, MD
About this study
Official title: Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan
Intravenous artesunate is egual to quinine in the treatment of severe malaria
Read the detailed description
Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time
- Conditions
- Malaria
- Being tested
- artesunate, Quinine
- Keywords
- severe, Falciaparum, Malaria
- Medical subject headings
- Malaria, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunateDrug
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
QuinineDrug
quinine infusion 80 mg/kg every 8 hours till the patient can take orally
| Study group | Role | What they receive |
|---|---|---|
| artesunate | Experimental | intravenous artesunate 80 mg/kg initially then after 8 hours then daily Receives: Drug: artesunate; Drug: Quinine |
| quinine | Active comparator | quinine infusion 80 mg/kg every 8 hours Receives: Drug: artesunate; Drug: Quinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance of the parasite and fever
To compare the parasite clearance time and fever clearance time between the two groups
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013 (estimated)
- Study completionJul 2013 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kassala, Sudan, Kassala, Sudan
- Responsible party
- Principal investigator, Ishag Adam, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805232
- Sponsor's protocol ID
- artesunate and malaria
- Acronym
- IVAS
- Status last verified
- Mar 2013
- First submitted
- 2 Mar 2013
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Eltahir HG, Omer AA, Mohamed AA, Adam I. Comparison of artesunate and quinine in the treatment of Sudanese children with severe Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2010 Oct;104(10):684-6. doi: 10.1016/j.trstmh.2010.05.009. Epub 2010 Jun 17.
PubMed 20850004
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan
- ClinicalTrials.gov ID
- NCT01805232
- Acronym / sponsor ID
- IVAS / artesunate and malaria
- Conditions
- Malaria
- Keywords
- severe, Falciaparum, Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- University of Kassala, Sudan, Kassala, Sudan
- Study start
- Mar 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 6 Mar 2013 (estimated)
- 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.
Intravenous artesunate is egual to quinine in the treatment of severe malaria
Detailed description
Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artesunate | Experimental | Drug: artesunate, Drug: Quinineintravenous artesunate 80 mg/kg initially then after 8 hours then daily |
| quinine | Active comparator | Drug: artesunate, Drug: Quininequinine infusion 80 mg/kg every 8 hours |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- severe P.falciparum malaria-
Key exclusion criteria (1 listed)
- mixed infection Pregnant women -
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 |
|---|---|---|
| artesunateintravenous artesunate 80 mg/kg initially then after 8 hours then daily | Drug | artesunate, quinine |
| Quininequinine infusion 80 mg/kg every 8 hours till the patient can take orally | Drug | artesunate, quinine |
Primary outcome
clearance of the parasite and fever
Time frame: 3 days
To compare the parasite clearance time and fever clearance time between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Background: PubMed 20850004Eltahir HG, Omer AA, Mohamed AA, Adam I. Comparison of artesunate and quinine in the treatment of Sudanese children with severe Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2010 Oct;104(10):684-6. doi: 10.1016/j.trstmh.2010.05.009. Epub 2010 Jun 17.
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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.
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 and Quinine in people with Malaria, run by University of Khartoum at 1 site in Sudan.
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: status not confirmed, as of the sponsor's last update on 6 Mar 2013. 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 Sudan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clearance of the parasite and fever (time frame: 3 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 NCT01805232, 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 6 Mar 2013; AzTrials last refreshed its copy on 1 Nov 2026.