Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a simple antibiotic combo save more newborns?

NCT ID NCT07183462

Disease control Sponsor: Sheba Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding azithromycin to the standard antibiotic ampicillin can reduce serious health problems in newborns when a mother's water breaks early (between 34 and 37 weeks). About 311 women with a single pregnancy will receive either ampicillin alone or ampicillin plus azithromycin while in the hospital until delivery. The goal is to see if the combination lowers the risk of breathing issues, infections, or other complications in the baby.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 311 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Maternal age 18-50 * Premature rupture of membranes * Gestational age 34.0 and 36.4 weeks * Singleton pregnancy Exclusion Criteria: * Multiple gestations * Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes) * Meconium stain amniotic fluid * Non-reassuring fetal heart rate or status * Maternal or fetal indication for labor: * Suspected Chorioamnionitis * Suspected placental abruption * Any maternal morbidity requiring labor * Cervical cerclage in place. * Major fetal malformation or known chromosomal abnormalities. * Stillbirth. * Sensitivity to Macrolides Antibiotics

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Antibiotic prophylaxis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities perinatal disease Pregnancy Complications, Infectious Premature Birth preterm premature rupture of the membranes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibiotic prophylaxis Latency period Neonatal diseases and abnormalities Pregnancy complications, infectious Premature birth Prematurity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sheba medical center

    RECRUITING

    Ramat Gan, Israel, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.