MalariaPhase 3NCT01065116
Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
A Phase 3 study testing AL Blister-packs with Instruction leaflets and AL unit dose age specific pre-packs in people with Malaria, run by Malaria Consortium, Uganda at 1 site in Uganda.
Trial summary
The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs. Read more about this study
- Who is it for?
- Ages 4 months to 7 years
- Conditions the study is for
- Malaria
- What is being tested?
- AL Blister-packs with Instruction leaflets and AL unit dose age specific pre-packs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2010to Nov 2010
- Phase
- Phase 3
- 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 4 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50C.
- Weight between 5 kg and 25 kg
- Positive malaria smear results for P. falciparum
- No history of intake of AL in the preceding two weeks
- Able to tolerate oral therapy
- Caregiver has given written informed consent to participate in the study
- If they reside within the designated catchment area of the health facility
Who cannot join
- Features of life threatening illness including severe malaria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda
The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.
Read the detailed description
Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. Uganda adopted Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. However, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. This study will assess if AL blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector
- Conditions
- Malaria
- Being tested
- AL Blister-packs with Instruction leaflets, AL unit dose age specific pre-packs
- Keywords
- Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL Blister-packs with Instruction leafletsDrug
Also called Coartem Blister packs
AL Blister packs with instruction leaflets will be dispensed
AL unit dose age specific pre-packsDrug
Also called Coartem pre-packs
Age specific colour coded Unit dose pre-packs will be used
| Study group | Role | What they receive |
|---|---|---|
| AL Blister-pack | Experimental | Not described Receives: Drug: AL Blister-packs with Instruction leaflets |
| AL unit dose age specific pre-packs | Active comparator | Not described Receives: Drug: AL unit dose age specific pre-packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.
Measured: Day 3
Secondary outcomes (2)
Parasitological cure rates
Measured: Day 28
Clinical cure rates
Measured: Days 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaria Consortium, Uganda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda, Makerere University
- Investigators
- Joaniter I Nankabirwa, MSc CEB, Principal investigator, Makerere University Kampala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065116
- Sponsor's protocol ID
- COMDIS -Blisterpack
- Status last verified
- May 2010
- First submitted
- 8 Feb 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda
- ClinicalTrials.gov ID
- NCT01065116
- Acronym / sponsor ID
- COMDIS -Blisterpack
- Conditions
- Malaria
- Keywords
- Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Malaria Consortium, UgandaUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda, Makerere University
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 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.
The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.
Detailed description
Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. Uganda adopted Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. However, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. This study will assess if AL blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL Blister-pack | Experimental | Drug: AL Blister-packs with Instruction leaflets |
| AL unit dose age specific pre-packs | Active comparator | Drug: AL unit dose age specific pre-packs |
Who may qualify
- Ages
- 4 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50C.
- Weight between 5 kg and 25 kg
- Positive malaria smear results for P. falciparum
- No history of intake of AL in the preceding two weeks
- Able to tolerate oral therapy
Key exclusion criteria (1 listed)
- Features of life threatening illness including severe malaria
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 |
|---|---|---|
| AL Blister-packs with Instruction leafletsAlso: Coartem Blister packsAL Blister packs with instruction leaflets will be dispensed | Drug | AL Blister-pack |
| AL unit dose age specific pre-packsAlso: Coartem pre-packsAge specific colour coded Unit dose pre-packs will be used | Drug | AL unit dose age specific pre-packs |
Primary outcome
Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.
Time frame: Day 3
2 secondary outcomes
Parasitological cure rates
Time frame: Day 28
Clinical cure rates
Time frame: Days 3
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 21 Jul 2011.
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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.
Joaniter I Nankabirwa, MSc CEB principal investigator
Makerere University Kampala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL Blister-packs with Instruction leaflets and AL unit dose age specific pre-packs in people with Malaria, run by Malaria Consortium, Uganda 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 7 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 21 Jul 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report. (time frame: Day 3). 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 21 Jul 2011.