Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali

Summary

The LAKANA trial will assess the impact on mortality and other health outcomes of quarterly and biannual azithromycin mass drug administration (MDA) when delivered to 1-11-month (29-364 days) old infants in a high-mortality setting where malaria is holoendemic but there is also a functioning seasonal malaria chemoprevention (SMC) program in place. The long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality, and to determine the most effective treatment regimen. The main study hypotheses in terms of mortality effect are: i) Biannual azithromycin MDA to 1-11 month old infants reduces their mortality, ii) Quarterly azithromycin MDA to 1-11 month old infants reduces their mortality, iii) Quarterly azithromycin MDA has a bigger mortality effect than biannual MDA.

Conditions

• Mortality

Interventions

DRUG

Placebo

Placebo mixture will be administered as a single dose in oral suspension form for children 1-11 months of age. Weight-based dosing will be used: single-dose of 0.5 ml / kg child weight.

DRUG

Azithromycin

Azithromycin will be administered as a single dose in oral suspension form for children 1-11 months of age. Weight-based dosing will be used: single-dose of 0.5 ml (20 mg) / kg child weight.

Sponsors & Collaborators

• Center for Vaccine Development CVD-Mali, Bamako, Mali

  collaborator UNKNOWN

• University College London Hospitals

  collaborator OTHER

• Tro Da Ltd, UK

  collaborator UNKNOWN

• Duke-NUS Graduate Medical School

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Pfizer Inc. (Provider of study drugs)

  collaborator UNKNOWN

• Tampere University

  lead OTHER

Principal Investigators

• Per Ashorn, MD, PhD · Center for Child Health Research, Tampere University

• Ulla Ashorn, PhD · Center for Child Health Research, Tampere University

• Samba Sow, MD, MSc · Center for Vaccine Development CVD-Mali

• Nigel Klein, MBBS, PhD · University College London Hospitals

• Camilla Ducker, MBBS, MSc · Tro Da Ltd, UK

• Yin Bun Cheung, PhD · Centre for Quantitative Medicine, Duke-NUS Medical School

• Dagmar Alber, PhD · University College London Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

29 Days

Max Age

364 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-15

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Mali

Study Locations