What side effects are associated with this type of intervention?

Azithromycin, a macrolide antibiotic, is commonly used to treat bacterial infections and has been shown to reduce child mortality. Common side effects include gastrointestinal issues such as diarrhea, nausea, and abdominal pain, as well as hypersensitivity reactions like skin eruptions. Prolonged use can lead to antibiotic resistance. Rare but serious side effects include liver enzyme abnormalities and cardiac arrhythmias.

What prior FDA approvals exist?

The FDA has approved several antibiotics to combat antibiotic resistance, including macrolides like azithromycin. Azithromycin is used to treat respiratory infections, skin infections, and sexually transmitted infections. Other related drugs include clindamycin, which is used for treating methicillin-resistant Staphylococcus aureus (MRSA) infections, and ceftaroline, a cephalosporin effective against MRSA and other resistant bacteria. These approvals aim to provide effective treatments against resistant bacterial strains, improving patient outcomes and addressing public health concerns.

What other types of research exist?

Promising alternatives to azithromycin for antibiotic-resistant patients in 2024 include linezolid, daptomycin, and ceftaroline. These antibiotics have shown efficacy against resistant strains and are considered safe for pediatric use. Consultation with an infectious disease expert is recommended to tailor the treatment to the specific infection and patient needs.

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Macrolide Antibiotic

Azithromycin for Pediatric Health (AVENIR Trial)

Phase 4

Recruiting

Led By Kieran O'Brien, PhD, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At the individual-level: Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment

At the individual-level: Age 1-11 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests giving an antibiotic called azithromycin to children aged 1-11 months in areas where many children die. The goal is to see if this reduces deaths by preventing infections. Azithromycin has been shown to reduce child mortality in various trials, particularly in sub-Saharan Africa.

Who is the study for?

The trial is for children aged 1-11 months in Niger, specifically from Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions. Caregivers must consent to participation. Children previously in MORDOR trials or with known macrolide allergies cannot join.

What is being tested?

Azithromycin for Oral Suspension is being tested to see if it can reduce child mortality when given twice a year to infants. The study will also monitor the impact on antibiotic resistance within programmatic settings.

What are the potential side effects?

While not detailed here, azithromycin may cause digestive issues like diarrhea and nausea, allergic reactions ranging from rashes to more severe responses, and could contribute to increased antibiotic resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 1-59 months or 7-12 years old, or I am the caregiver of an eligible child.

Select...

My child is between 1 to 11 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Load of genetic determinants of macrolide resistance from population-based samples

Prevalence of genetic determinants of macrolide resistance from population-based samples

Secondary study objectives

Load of genetic determinants of macrolide resistance from clinic-based samples

Number of all-cause clinic visits

Prevalence of genetic determinants of macrolide resistance from clinic-based samples

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Programmatic azithro 1-11Active Control1 Intervention

Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers

Group II: no interventionActive Control1 Intervention

No additional intervention.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Azithromycin, a macrolide antibiotic, combats bacterial infections by binding to the 50S ribosomal subunit, inhibiting protein synthesis and bacterial growth. This is vital for treating infections in antibiotic resistance patients. However, misuse can lead to resistance, where bacteria evolve to evade the drug through target site modification, efflux pumps, or enzymatic degradation. Understanding these mechanisms helps develop strategies to maintain antibiotic efficacy, crucial for reducing mortality, particularly in children.

Comparison of the Respiratory Resistomes and Microbiota in Children Receiving Short versus Standard Course Treatment for Community-Acquired Pneumonia.Trial of Three Rounds of Mass Azithromycin Administration for Yaws Eradication.Effect of the duration of antimicrobial exposure on the development of antimicrobial resistance (AMR) for macrolide antibiotics: protocol for a systematic review with a network meta-analysis.