MalariaPhase 3SMCAZNCT02211729
A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children
A Phase 3 study testing Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin in people with Malaria and Respiratory Infections, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Respiratory Infections
- What is being tested?
- Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22,090 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2014to 31 Dec 2017
- 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 3 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of either sex aged 3-59 months of age at the start of each period of drug administration
- parental consent is obtained.
Who cannot join
- a severe, chronic illness,
- a known allergy to one of the study drugs.
- HIV+ children on cotrimoxazole prophylaxis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ.
This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season.
Read more
Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded.
Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period
Secondary endpoints:
- incidence of the primary endpoint during the whole study period
- attendance at a study health centre with a nonmalaria febrile illness
- attendance at a study health centre with malaria,
- the prevalence of moderate anaemia at the end of each malaria transmission season,
- nutritional status at the end of each malaria transmission season,
- prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season,
- prevalence of resistance markers to SP at the end of the study,
Sample size: 19,200 children (9600 in each country) will be enrolled.
- Conditions
- Malaria, Respiratory Infections
- Being tested
- Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin, Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin
- Medical subject headings
- Malaria, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulphadoxine-Pyrimethamine+ Amodiaquine+ AzithromycinDrug
Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season
Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycinDrug
Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season
| Study group | Role | What they receive |
|---|---|---|
| Seasonal malaria chemoprevention | Active comparator | Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin Receives: Drug: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin |
| seasonal malaria chemoprevention plus AZ | Experimental | Sulphadoxine-Pyrimethamine+ Amodiaquine + Azithromycin 4 rounds during malaria transmission season Receives: Drug: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe morbidity and mortality
Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period.
Measured: from the time of enrolment upto the end of malaria transmission in year 3 ( the person time at risk will be restricted to three malaria transmission seasons)
Secondary outcomes (1)
macrolide resistant pneumococci carriage
Measured: before administration of first dose of SMC and at the end of malaria transmission season in year 1, 2 and 3,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startMay 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211729
- Sponsor's protocol ID
- MR/K007319/1
- Acronym
- SMCAZ
- Status last verified
- Mar 2018
- First submitted
- 17 Jul 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hema-Ouangraoua S, Tranchot-Diallo J, Zongo I, Kabore NF, Nikiema F, Yerbanga RS, Tinto H, Chandramohan D, Ouedraogo GA, Greenwood B, Ouedraogo JB. Impact of mass administration of azithromycin as a preventive treatment on the prevalence and resistance of nasopharyngeal carriage of Staphylococcus aureus. PLoS One. 2021 Oct 13;16(10):e0257190. doi: 10.1371/journal.pone.0257190. eCollection 2021.
PubMed 34644317Cairns ME, Sagara I, Zongo I, Kuepfer I, Thera I, Nikiema F, Diarra M, Yerbanga SR, Barry A, Tapily A, Coumare S, Milligan P, Tinto H, Ouedraogo JB, Chandramohan D, Greenwood B, Djimde A, Dicko A. Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Hounde District, Burkina Faso and Bougouni District, Mali. PLoS Med. 2020 Aug 21;17(8):e1003214. doi: 10.1371/journal.pmed.1003214. eCollection 2020 Aug.
PubMed 32822362Chandramohan D, Dicko A, Zongo I, Sagara I, Cairns M, Kuepfer I, Diarra M, Barry A, Tapily A, Nikiema F, Yerbanga S, Coumare S, Thera I, Traore A, Milligan P, Tinto H, Doumbo O, Ouedraogo JB, Greenwood B. Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention. N Engl J Med. 2019 Jun 6;380(23):2197-2206. doi: 10.1056/NEJMoa1811400. Epub 2019 Jan 30.
PubMed 30699301
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children
- ClinicalTrials.gov ID
- NCT02211729
- Acronym / sponsor ID
- SMCAZ / MR/K007319/1
- Conditions
- Malaria, Respiratory Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,090 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Study start
- May 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 7 Aug 2014 (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 primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ.
This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season.
Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded.
Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period
Secondary endpoints:
- incidence of the primary endpoint during the whole study period
- attendance at a study health centre with a nonmalaria febrile illness
- attendance at a study health centre with malaria,
- the prevalence of moderate anaemia at the end of each malaria transmission season,
- nutritional status at the end of each malaria transmission season,
- prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season,
- prevalence of resistance markers to SP at the end of the study,
Sample size: 19,200 children (9600 in each country) will be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seasonal malaria chemoprevention | Active comparator | Drug: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycinSulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin |
| seasonal malaria chemoprevention plus AZ | Experimental | Drug: Sulphadoxine-Pyrimethamine+ Amodiaquine+ AzithromycinSulphadoxine-Pyrimethamine+ Amodiaquine + Azithromycin 4 rounds during malaria transmission season |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of either sex aged 3-59 months of age at the start of each period of drug administration
- parental consent is obtained.
Key exclusion criteria (3 listed)
- a severe, chronic illness,
- a known allergy to one of the study drugs.
- HIV+ children on cotrimoxazole prophylaxis
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 |
|---|---|---|
| Sulphadoxine-Pyrimethamine+ Amodiaquine+ AzithromycinSulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season | Drug | seasonal malaria chemoprevention plus AZ |
| Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycinSulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season | Drug | Seasonal malaria chemoprevention |
Primary outcome
severe morbidity and mortality
Time frame: from the time of enrolment upto the end of malaria transmission in year 3 ( the person time at risk will be restricted to three malaria transmission seasons)
Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period.
1 secondary outcome
macrolide resistant pneumococci carriage
Time frame: before administration of first dose of SMC and at the end of malaria transmission season in year 1, 2 and 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 7 Mar 2018.
- Derived from this study: PubMed 34644317Hema-Ouangraoua S, Tranchot-Diallo J, Zongo I, Kabore NF, Nikiema F, Yerbanga RS, Tinto H, Chandramohan D, Ouedraogo GA, Greenwood B, Ouedraogo JB. Impact of mass administration of azithromycin as a preventive treatment on the prevalence and resistance of nasopharyngeal carriage of Staphylococcus aureus. PLoS One. 2021 Oct 13;16(10):e0257190. doi: 10.1371/journal.pone.0257190. eCollection 2021.
- Derived from this study: PubMed 32822362Cairns ME, Sagara I, Zongo I, Kuepfer I, Thera I, Nikiema F, Diarra M, Yerbanga SR, Barry A, Tapily A, Coumare S, Milligan P, Tinto H, Ouedraogo JB, Chandramohan D, Greenwood B, Djimde A, Dicko A. Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Hounde District, Burkina Faso and Bougouni District, Mali. PLoS Med. 2020 Aug 21;17(8):e1003214. doi: 10.1371/journal.pmed.1003214. eCollection 2020 Aug.
- Derived from this study: PubMed 30699301Chandramohan D, Dicko A, Zongo I, Sagara I, Cairns M, Kuepfer I, Diarra M, Barry A, Tapily A, Nikiema F, Yerbanga S, Coumare S, Thera I, Traore A, Milligan P, Tinto H, Doumbo O, Ouedraogo JB, Greenwood B. Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention. N Engl J Med. 2019 Jun 6;380(23):2197-2206. doi: 10.1056/NEJMoa1811400. Epub 2019 Jan 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin in people with Malaria and Respiratory Infections, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
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 2 inclusion and 3 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Mali. 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?
severe morbidity and mortality (time frame: from the time of enrolment upto the end of malaria transmission in year 3 ( the person time at risk will be restricted to three malaria transmission seasons)). 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 NCT02211729, 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 7 Mar 2018.