Malaria TransmissionPhase 4NCT01906788
The Optimal Timing Of Primaquine To Prevent Malaria Transmission After Artemisinin-Combination Therapy
A Phase 4 study testing Artemether Lumefantrine, Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0 and Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2 in people with Malaria Transmission, run by Kilimanjaro Clinical Research Institute at 1 site in Tanzania.
Trial summary
The investigators' Hypothesis is that "The correct timing of gametocytocidal drug in combination with an effective Artemisinin Combination Therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment" Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Malaria Transmission
- What is being tested?
- Artemether Lumefantrine, Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0 and Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTanzania
- Study dates
- May 2013to Oct 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 years - 17 years
- Residents of research area
- Willingness to come for complete scheduled follow-up.
- Uncomplicated malaria with P. falciparum mono-infection
- Axillary temperature > 37.5°C and < 39.5°C, or history of fever in previous 48 hours.
- No history of adverse reactions to study medication
- Understanding of the procedures of the study by parent or guardian and willing to participate by signing written informed consent forms
Who cannot join
- Haemoglobin below 9g/dl
- Inability to take drugs orally
- Known hypersensitivity to any of the drugs given
- Reported treatment with antimalarial chemotherapy in the past 2 weeks
- Evidence of chronic disease or acute infection other than malaria
- Domicile outside the study area
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- Signs of severe malaria( such as respiratory distress, altered consciousness deep breathing, anaemia)
- Participating in other malaria studies conducted in the region
- Mixed malaria parasite species infection
- Positive pregnant test by Urine (UPT) if participant is female aged above 12 years
- G6PD deficient using the fluorescence spot test
Trial locations and contacts
1 site in 1 country.
Tanzania1 site, 1 recruiting
- Recruiting
Bagamoyo Research and Training Centre
Bagamoyo
Seif Shekalaghe, MD, PhD, +255 755 470472, sshekalaghe@ihi.or.tz
Chris Drakeley, PhD
About this study
Official title: THE OPTIMAL TIMING OF PRIMAQUINE TO PREVENT MALARIA TRANSMISSION AFTER ARTEMISININ-COMBINATION THERAPY
The investigators' Hypothesis is that "The correct timing of gametocytocidal drug in combination with an effective Artemisinin Combination Therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment"
Read the detailed description
Global malaria elimination is back on the agenda, gametocytocidal drugs such as primaquine are currently advocated for use in the interventions that aim to interrupt malaria transmission and hence elimination. Mature gametocytes are responsible for malaria transmission. Artemisinin based combination therapies (ACTs) has limited effect on the young gametocytes. Primaquine is able to clear mature gametocytes that remain after treatment with ACTs. Complete clearance of mature gametocytes will depend on the ideal time primaquine is given after ACT. It is important therefore that is administered at optimal time in order to have significant impact on clearing gametocytes to interrupt malaria transmission. An additional consideration is operational administration of Primaquine and compliance both of which are likely to be enhanced if the drug is administered on the day of diagnosis.
In this study, the investigators aim to determine optimal timing of primaquine administration in addition to ACT by comparing administration on day 0 with administration on day 2.
The investigators' primary end points are gametocyte prevalence and density by microscopy and Quantitative Nucleic Acid Based Amplification (QT-NASBA) on day 14, which will be compared between the two primaquine treatment arms.
- Conditions
- Malaria Transmission
- Being tested
- Artemether Lumefantrine, Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0, Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether LumefantrineDrug
Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0Drug
Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2Drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Active comparator: Artemether Lumefantrine 6 dose regime orally Receives: Drug: Artemether Lumefantrine |
| Group 2 | Experimental | Experimental: Artemether Lumefantrine 6 dose regime Plus single dose Primaquine (0.75/kg) on day 0 Receives: Drug: Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0 |
| Group 3 | Experimental | Experimental: Artemether Lumefantrine 6 dose regimen plus single dose of Primaquine (0.75/kg) on day 2 Receives: Drug: Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gametocyte prevalence and density by microscopy and QT-NASBA
By microscopy and QT-NASBA techniques we will determine and compare gametocyte prevalence and density on day 14 between the Primaquine treatment 2 and 3 arms.
Measured: Day 14
Secondary outcomes (1)
Haemoglobin level
We will compare the level of baseline haemoglobin on days 3, 7, 10 and 14 after the start of treatment between the two Primaquine arms
Measured: days 3, 7, 10 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013 (estimated)
- Study completionOct 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 Malaria TransmissionStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kilimanjaro Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Ifakara Health Institute
- Responsible party
- Sponsor
- Investigators
- Seif Shekalaghe, MD, PhD, Principal investigator, Kilimanjaro Clinical Research Institute and Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906788
- Sponsor's protocol ID
- PRIMAQUINE STUDY
- Status last verified
- Jul 2013
- First submitted
- 20 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shekalaghe S, Mosha D, Hamad A, Mbaga TA, Mihayo M, Bousema T, Drakeley C, Abdulla S. Optimal timing of primaquine to reduce Plasmodium falciparum gametocyte carriage when co-administered with artemether-lumefantrine. Malar J. 2020 Jan 21;19(1):34. doi: 10.1186/s12936-020-3121-3.
PubMed 31964380
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE OPTIMAL TIMING OF PRIMAQUINE TO PREVENT MALARIA TRANSMISSION AFTER ARTEMISININ-COMBINATION THERAPY
- ClinicalTrials.gov ID
- NCT01906788
- Acronym / sponsor ID
- PRIMAQUINE STUDY
- Conditions
- Malaria Transmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kilimanjaro Clinical Research InstituteUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Ifakara Health Institute
- Study start
- May 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 24 Jul 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.
The investigators' Hypothesis is that "The correct timing of gametocytocidal drug in combination with an effective Artemisinin Combination Therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment"
Detailed description
Global malaria elimination is back on the agenda, gametocytocidal drugs such as primaquine are currently advocated for use in the interventions that aim to interrupt malaria transmission and hence elimination. Mature gametocytes are responsible for malaria transmission. Artemisinin based combination therapies (ACTs) has limited effect on the young gametocytes. Primaquine is able to clear mature gametocytes that remain after treatment with ACTs. Complete clearance of mature gametocytes will depend on the ideal time primaquine is given after ACT. It is important therefore that is administered at optimal time in order to have significant impact on clearing gametocytes to interrupt malaria transmission. An additional consideration is operational administration of Primaquine and compliance both of which are likely to be enhanced if the drug is administered on the day of diagnosis.
In this study, the investigators aim to determine optimal timing of primaquine administration in addition to ACT by comparing administration on day 0 with administration on day 2.
The investigators' primary end points are gametocyte prevalence and density by microscopy and Quantitative Nucleic Acid Based Amplification (QT-NASBA) on day 14, which will be compared between the two primaquine treatment arms.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Artemether LumefantrineActive comparator: Artemether Lumefantrine 6 dose regime orally |
| Group 2 | Experimental | Drug: Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0Experimental: Artemether Lumefantrine 6 dose regime Plus single dose Primaquine (0.75/kg) on day 0 |
| Group 3 | Experimental | Drug: Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2Experimental: Artemether Lumefantrine 6 dose regimen plus single dose of Primaquine (0.75/kg) on day 2 |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 3 years - 17 years
- Residents of research area
- Willingness to come for complete scheduled follow-up.
- Uncomplicated malaria with P. falciparum mono-infection
- Axillary temperature > 37.5°C and < 39.5°C, or history of fever in previous 48 hours.
Key exclusion criteria (11 listed)
- Haemoglobin below 9g/dl
- Inability to take drugs orally
- Known hypersensitivity to any of the drugs given
- Reported treatment with antimalarial chemotherapy in the past 2 weeks
- Evidence of chronic disease or acute infection other than 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 |
|---|---|---|
| Artemether Lumefantrine | Drug | Group 1 |
| Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0 | Drug | Group 2 |
| Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2 | Drug | Group 3 |
Primary outcome
Gametocyte prevalence and density by microscopy and QT-NASBA
Time frame: Day 14
By microscopy and QT-NASBA techniques we will determine and compare gametocyte prevalence and density on day 14 between the Primaquine treatment 2 and 3 arms.
1 secondary outcome
Haemoglobin level
Time frame: days 3, 7, 10 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
- Derived from this study: PubMed 31964380Shekalaghe S, Mosha D, Hamad A, Mbaga TA, Mihayo M, Bousema T, Drakeley C, Abdulla S. Optimal timing of primaquine to reduce Plasmodium falciparum gametocyte carriage when co-administered with artemether-lumefantrine. Malar J. 2020 Jan 21;19(1):34. doi: 10.1186/s12936-020-3121-3.
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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.
Seif Shekalaghe, MD, PhD principal investigator
Kilimanjaro Clinical Research Institute and Ifakara Health Institute
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, Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0 and Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2 in people with Malaria Transmission, run by Kilimanjaro Clinical Research Institute 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 7 inclusion and 11 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 24 Jul 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 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?
Contact Seif Shekalaghe, MD, PhD (+255 755 470472, sshekalaghe@ihi.or.tz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gametocyte prevalence and density by microscopy and QT-NASBA (time frame: Day 14). 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 NCT01906788, 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 24 Jul 2013.