Uncomplicated MalariaPhase 4QALENCT00540202
Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
A Phase 4 study testing artemether-lumefantrine and Oral quinine in people with Uncomplicated Malaria, run by Makerere University at 1 site in Uganda.
Trial summary
We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Uncomplicated Malaria
- What is being tested?
- artemether-lumefantrine and Oral quinine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2007to Apr 2008
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 6 and 59 months of age seen at the assessment centre during the study period
- With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
- With a microscopically confirmed monoinfection of Plasmodium falciparum
- Able to tolerate oral therapy,
- Whose parents/guardians have provided written informed consent.
Who cannot join
- Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
- Evidence of severe malaria.
- Residence at more than 20km from the health clinic.
- Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mulago National Referral Hospital
Kampala, Central Region, 256
Jane Achan, MMed, +256-772-410183, achanj@yahoo.co.uk
Catherine Maiteki, MD, +256-712-840449, cmaiteki@yahoo.com
About this study
We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.
Read the detailed description
This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented
- Conditions
- Uncomplicated Malaria
- Being tested
- artemether-lumefantrine, Oral quinine
- Keywords
- Effectiveness, Oral quinine, Coartem, Uncomplicated malaria, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artemether-lumefantrineDrug
Also called Coartem
Tablets taken twice daily for 3 days according to weight based guidelines.
Oral quinineDrug
Quinine tablets given at 10mg/kg 8 hourly for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1.Oral quinine | Experimental | Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days Receives: Drug: Oral quinine |
| 2. Coartem | Active comparator | Tablets Receives: Drug: artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.
Measured: 28 days
Secondary outcomes (1)
1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startSep 2007
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated 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
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda, Uganda Malaria Surveillance Project
- Investigators
- Ambrose O Talisuna, PhD, Principal investigator, Ministry of Health, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540202
- Sponsor's protocol ID
- QALE07
- Acronym
- QALE
- Status last verified
- Oct 2007
- First submitted
- 4 Oct 2007
- Last updated
- 5 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fogg C, Bajunirwe F, Piola P, Biraro S, Checchi F, Kiguli J, Namiiro P, Musabe J, Kyomugisha A, Guthmann JP. Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda. Am J Trop Med Hyg. 2004 Nov;71(5):525-30.
PubMed 15569777de Vries PJ, Bich NN, Van Thien H, Hung LN, Anh TK, Kager PA, Heisterkamp SH. Combinations of artemisinin and quinine for uncomplicated falciparum malaria: efficacy and pharmacodynamics. Antimicrob Agents Chemother. 2000 May;44(5):1302-8. doi: 10.1128/AAC.44.5.1302-1308.2000.
PubMed 10770766Achan J, Tibenderana JK, Kyabayinze D, Wabwire Mangen F, Kamya MR, Dorsey G, D'Alessandro U, Rosenthal PJ, Talisuna AO. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial. BMJ. 2009 Jul 21;339:b2763. doi: 10.1136/bmj.b2763.
PubMed 19622553
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
- ClinicalTrials.gov ID
- NCT00540202
- Acronym / sponsor ID
- QALE / QALE07
- Conditions
- Uncomplicated Malaria
- Keywords
- Effectiveness, Oral quinine, Coartem, Uncomplicated malaria, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda, Uganda Malaria Surveillance Project
- Study start
- Sep 2007
- Study completion
- Apr 2008 (estimated)
- First posted
- 5 Oct 2007 (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.
We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.
Detailed description
This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Oral quinine | Experimental | Drug: Oral quininePatients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days |
| 2. Coartem | Active comparator | Drug: artemether-lumefantrineTablets |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged between 6 and 59 months of age seen at the assessment centre during the study period
- With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
- With a microscopically confirmed monoinfection of Plasmodium falciparum
- Able to tolerate oral therapy,
- Whose parents/guardians have provided written informed consent.
Key exclusion criteria (4 listed)
- Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
- Evidence of severe malaria.
- Residence at more than 20km from the health clinic.
- Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness
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 |
|---|---|---|
| artemether-lumefantrineAlso: CoartemTablets taken twice daily for 3 days according to weight based guidelines. | Drug | 2. Coartem |
| Oral quinineQuinine tablets given at 10mg/kg 8 hourly for 7 days | Drug | 1.Oral quinine |
Primary outcome
1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.
Time frame: 28 days
1 secondary outcome
1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2007.
- Background: PubMed 15569777Fogg C, Bajunirwe F, Piola P, Biraro S, Checchi F, Kiguli J, Namiiro P, Musabe J, Kyomugisha A, Guthmann JP. Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda. Am J Trop Med Hyg. 2004 Nov;71(5):525-30.
- Background: PubMed 10770766de Vries PJ, Bich NN, Van Thien H, Hung LN, Anh TK, Kager PA, Heisterkamp SH. Combinations of artemisinin and quinine for uncomplicated falciparum malaria: efficacy and pharmacodynamics. Antimicrob Agents Chemother. 2000 May;44(5):1302-8. doi: 10.1128/AAC.44.5.1302-1308.2000.
- Derived from this study: PubMed 19622553Achan J, Tibenderana JK, Kyabayinze D, Wabwire Mangen F, Kamya MR, Dorsey G, D'Alessandro U, Rosenthal PJ, Talisuna AO. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial. BMJ. 2009 Jul 21;339:b2763. doi: 10.1136/bmj.b2763.
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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.
Ambrose O Talisuna, PhD principal investigator
Ministry of Health, Uganda
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 artemether-lumefantrine and Oral quinine in people with Uncomplicated Malaria, run by Makerere University at 1 site in Uganda.
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 5 inclusion and 4 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 5 Oct 2007. 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 Uganda. 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 Jane Achan, MMed (+256-772-410183, achanj@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. (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 NCT00540202, which also lists 3 linked publications.
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 5 Oct 2007.