Non-routine Use of Antibiotics (Amoxi-light)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2876 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate, in routine operational settings of treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months, the risk of nutritional recovery and hospitalization with non-routine use of amoxicillin compared to the risk achieved with systematic use of antibiotics.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RCT of Efficacy of Amoxicillin Over Ampicillin on Severe Pneumonia

NCT03369093

Treatment Failure Lethargy Altered Mental Status +3 more

COMPLETED NA

Outcome of Patients After a Negative Oral Challenge to Amoxicillin

NCT04922034

Negative Challenge to Amoxicillin

COMPLETED

Delayed Antibiotic Therapy in General Practice

NCT05361239

AOM - Acute Otitis Media

COMPLETED

Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment (MAX-AMOX)

NCT04070469

Infection, Bacterial

COMPLETED PHASE4

Equivalency Of Oral Amoxicillin Vs Injectable Penicillin In Children With Severe Pneumonia

NCT00227331

Pneumonia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Upon admission, all children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics. Antibiotics will be provided at admission and during follow-up only if clinically justified. The results of the program (ie, nutritional recovery, hospitalization, death and abandonment) will be monitored in all children aged 6 to 59 months admitted for outpatient therapy in 2 outpatient treatment sites in the Madarounfa health district in Niger.

To ensure that the children included in the study receive appropriate care, the study will ask the children's leaders to return to the clinic for medical surveillance in the event of a clinical complication. Program staff will facilitate appropriate management, including prescription of antibiotics if clinically justified, and transfer to hospital of all children in need of close supervision and / or comprehensive medical management.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Acute Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard medical care

All children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 6-59 months
* Direct admission for the treatment of uncomplicated SAM (MUAC \<115 mm or PTZ \<-3 and / or presence of Grade + or ++ nutritional edema and moderate or good appetite with absence of medical complications)
* Signed Informed Consent

Exclusion Criteria

* No Informed Consent given
* Not directly admitted for the treatment of uncomplicated SAM at the CRENAS (Center for Outpatient Nutritional Rehabilitation for Malnutrition) of the study

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No