MalariaPhase 4NCT01075945
Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan
A Phase 4 study testing Dihydroartemisinin- piperaquine and artemether- lumefantrine in people with Malaria, run by University of Khartoum at 1 site in Sudan.
Trial summary
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine Read more about this study
- Who is it for?
- Ages 5 to 95 years
- Conditions the study is for
- Malaria
- What is being tested?
- Dihydroartemisinin- piperaquine and artemether- lumefantrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSudan
- Study dates
- Feb 2010to Apr 2010
- 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 5 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Uncomplicated malaria
Who cannot join
- Severe cases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Sudan1 site, 1 recruiting
- Recruiting
Sinnar
Cinnar, Blue Nile, 11111
Ishag Adam, Md, PhD, +249912168988, ishagadam@hotmail.com
Fatih M Malik, MD, +249911259199, ishagadamm@yahoo.com
About this study
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine
- Conditions
- Malaria
- Being tested
- Dihydroartemisinin- piperaquine, artemether- lumefantrine
- Keywords
- antimalarials, ACTs, Piperaquine, uncomplicated
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin- piperaquineDrug
Also called Hoy-Cotec
three tablets per day
artemether- lumefantrineDrug
Also called Coartem
twenty tablet in eight doses
| Study group | Role | What they receive |
|---|---|---|
| Dihydroartemisinin- piperaquine | Experimental | orally tablets Receives: Drug: Dihydroartemisinin- piperaquine; Drug: artemether- lumefantrine |
| artemether- lumefantrine | Active comparator | oral tablets Receives: Drug: artemether- lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the cure rate between the two drugs
PCR cure rate Parasite clearance time Fever clearance time
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075945
- Sponsor's protocol ID
- DP v AL01
- Other IDs
- DP v AL01aasudan, wadadam
- Status last verified
- Feb 2010
- First submitted
- 18 Feb 2010
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adam I, Elmardi KA, Malik EM. Predictors of antimalarial treatment failure in an area of unstable malaria transmission in eastern Sudan. Trans R Soc Trop Med Hyg. 2009 Jan;103(1):21-4. doi: 10.1016/j.trstmh.2008.07.005. Epub 2008 Aug 20.
PubMed 18718621
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan
- ClinicalTrials.gov ID
- NCT01075945
- Acronym / sponsor ID
- DP v AL01
- Conditions
- Malaria
- Keywords
- antimalarials, ACTs, Piperaquine, uncomplicated
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- Southeast University, China
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 25 Feb 2010 (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.
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dihydroartemisinin- piperaquine | Experimental | Drug: Dihydroartemisinin- piperaquine, Drug: artemether- lumefantrineorally tablets |
| artemether- lumefantrine | Active comparator | Drug: artemether- lumefantrineoral tablets |
Who may qualify
- Ages
- 5 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Uncomplicated malaria
Key exclusion criteria (2 listed)
- Severe cases
- Pregnancy
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 |
|---|---|---|
| Dihydroartemisinin- piperaquineAlso: Hoy-Cotecthree tablets per day | Drug | Dihydroartemisinin- piperaquine |
| artemether- lumefantrineAlso: Coartemtwenty tablet in eight doses | Drug | Dihydroartemisinin- piperaquine, artemether- lumefantrine |
Primary outcome
comparing the cure rate between the two drugs
Time frame: 3 months
PCR cure rate Parasite clearance time Fever clearance time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
- Background: PubMed 18718621Adam I, Elmardi KA, Malik EM. Predictors of antimalarial treatment failure in an area of unstable malaria transmission in eastern Sudan. Trans R Soc Trop Med Hyg. 2009 Jan;103(1):21-4. doi: 10.1016/j.trstmh.2008.07.005. Epub 2008 Aug 20.
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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 Dihydroartemisinin- piperaquine and artemether- lumefantrine 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 2 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 25 Feb 2010. 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?
Contact Ishag Adam, MD, PhD (+249912168988, ishagadam@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the cure rate between the two drugs (time frame: 3 months). 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 NCT01075945, 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 25 Feb 2010.