MalariaPhase 4NCT00465257
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar
A Phase 4 study testing artesunate + amodiaquine in people with Malaria, run by Karolinska University Hospital at 1 site in Tanzania.
Trial summary
The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- artesunate + amodiaquine
- How many people
- 110 participants
- Where
- 1 siteTanzania
- Study dates
- May 2007to not given
- 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 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age below 60 months
- Weight ≥5kg
- No general danger signs or severe malaria present (see 4.4.2.1 \& 4.4.2.2)
- History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
- No other cause of fever is detectable
- No severe malnutrition
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- Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
- Guardian/Patient has understood the procedures of the study and is willing to participate
- Patient able to come for stipulated follow up visits and has easy access to the Study Site
Who cannot join
- Not able to drink or breastfeed
- Persistent Vomiting
- Recent history of convulsions
- Lethargic or unconscious
- Unable to sit or stand (as appropriate for age)
- History of allergy to test drugs
- History of intake of any drugs other than paracetamol and aspirin within 3 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar
The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.
- Conditions
- Malaria
- Being tested
- artesunate + amodiaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunate + amodiaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR adjusted parasitological cure rate by day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startMay 2007
Why it stopped: Due to lack of malaria patients in Zanzibar the study has been suspended.
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.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Anders Björkman, Professor, Study director, Karolinska UHGuida Rotlland, MD, MPH, Principal investigator, Karolinska UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465257
- Sponsor's protocol ID
- ACOIII
- Status last verified
- May 2008
- First submitted
- 23 Apr 2007
- Last updated
- 20 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar
- ClinicalTrials.gov ID
- NCT00465257
- Acronym / sponsor ID
- ACOIII
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to lack of malaria patients in Zanzibar the study has been suspended.
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- May 2007
- First posted
- 24 Apr 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.
The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age below 60 months
- Weight ≥5kg
- No general danger signs or severe malaria present (see 4.4.2.1 \& 4.4.2.2)
- History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
- No other cause of fever is detectable
Key exclusion criteria (7 listed)
- Not able to drink or breastfeed
- Persistent Vomiting
- Recent history of convulsions
- Lethargic or unconscious
- Unable to sit or stand (as appropriate for age)
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 |
|---|---|---|
| artesunate + amodiaquine | Drug | – |
Primary outcome
PCR adjusted parasitological cure rate by day 42.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
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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.
Anders Björkman, Professor study director
Karolinska UH
Guida Rotlland, MD, MPH principal investigator
Karolinska UH
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 + amodiaquine in people with Malaria, run by Karolinska University Hospital at 1 site in Tanzania.
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 9 inclusion and 7 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: paused, as of the sponsor's last update on 20 May 2008. 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 Tanzania. 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?
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?
PCR adjusted parasitological cure rate by day 42.. 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 20 May 2008.