Evidence map›Paper›PMID 37968741›Full record

Trial reportTrials2023

Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1-11-month-old infants in Mali.

Juho Luoma, Laura Adubra, Dagmar Alber, Per Ashorn, Ulla Ashorn, Elaine Cloutman-Green, Fatoumata Diallo, Camilla Ducker, Riku Elovainio, Yue-Mei Fan and 11 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04424511 (LAKANA , a Cluster-randomized, Double-blinded, Parallel Group, Controlled Trial, Testing the Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Rural Mali.), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04424511 phase3completednot on this map

LAKANA , a Cluster-randomized, Double-blinded, Parallel Group, Controlled Trial, Testing the Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Rural Mali.

TypeinterventionalSponsorTampere UniversityRan2020 to 2024Enrolled149,201ConditionsMortalityArmsPlacebo, Azithromycin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Non-typhoidalJAC-antimicrobial resistance · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 5 institutions in 4 countries.

Juho LuomaCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland. Juho.Luoma@tuni.fi.ORCID http://orcid.org/0000-0003-0008-8295
Laura AdubraCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Dagmar AlberGreat Ormond Street Institute of Child Health, University College London, London, UK.
Per AshornCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Ulla AshornCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Elaine Cloutman-GreenGreat Ormond Street Institute of Child Health, University College London, London, UK.
Fatoumata DialloCenter for Vaccine Development, Bamako, Mali.
Camilla DuckerTro Da Ltd, Cardiff, UK.
Riku ElovainioCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Yue-Mei FanCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Lily GatesGreat Ormond Street Institute of Child Health, University College London, London, UK.
Gwydion GruffuddTro Da Ltd, Cardiff, UK.
Tiia HaapaniemiCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Fadima HaidaraCenter for Vaccine Development, Bamako, Mali.
Lotta HallamaaCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Rikhard IhamuotilaCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Nigel KleinGreat Ormond Street Institute of Child Health, University College London, London, UK.
Owen MartellTro Da Ltd, Cardiff, UK.
Samba SowCenter for Vaccine Development, Bamako, Mali.
Taru VehmastoCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Yin Bun CheungCenter for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Tampere University · FIGreat Ormond Street Hospital · GBCentre Pour le Développement des Vaccins-Mali · MLVelindre NHS Trust · GBTampere University · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin (LAKANA) trial in Mali aims to evaluate the efficacy and safety of azithromycin (AZI) mass drug administration (MDA) to 1-11-month-old infants as well as the impact of the intervention on antimicrobial resistance (AMR) and mechanisms of action of azithromycin. To improve the transparency and quality of this clinical trial, we prepared this statistical analysis plan (SAP). METHODS/

designLAKANA is a cluster randomized trial that aims to address the mortality and health impacts of biannual and quarterly AZI MDA. AZI is given to 1-11-month-old infants in a high-mortality setting where a seasonal malaria chemoprevention (SMC) program is in place. The participating villages are randomly assigned to placebo (control), two-dose AZI (biannual azithromycin-MDA), and four-dose AZI (quarterly azithromycin-MDA) in a 3:4:2 ratio. The primary outcome of the study is mortality among the intention-to-treat population of 1-11-month-old infants. We will evaluate relative risk reduction between the study arms using a mixed-effects Poisson model with random intercepts for villages, using log link function with person-years as an offset variable. We will model outcomes related to secondary objectives of the study using generalized linear models with considerations on clustering.

conclusionThe SAP written prior to data collection completion will help avoid reporting bias and data-driven analysis for the primary and secondary aims of the trial. If there are deviations from the analysis methods described here, they will be described and justified in the publications of the trial results.

trial registrationClinicalTrials.gov ID NCT04424511 . Registered on 11 June 2020.

Indexed as

AzithromycinMalariaAnti-Bacterial AgentsChemopreventionDouble-Blind MethodHumansInfantMaliMass Drug AdministrationAnti-Bacterial AgentsAzithromycinAntibioticAntimicrobial resistanceAzithromycinCluster randomized trialGrowthInflammationMorbidityMortalityStatistical analysis plan

Identifiers

PMID37968741
PMCPMC10648361
OpenAlexW4388702990

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.