NCT06377397 (SAUNA) is a Phase 3 clinical trial of Antibiotics in Sepsis, sponsored by Indian Council of Medical Research.

Who is sponsoring NCT06377397?

NCT06377397 is sponsored by Indian Council of Medical Research.

What drugs are being tested in NCT06377397?

Interventions in NCT06377397: Antibiotics.

What condition does NCT06377397 study?

NCT06377397 studies Sepsis, PROM, Preterm (Pregnancy), Early-Onset Neonatal Sepsis, Preterm Premature Rupture of Membrane, Preterm Birth.

Is NCT06377397 still recruiting?

NCT06377397 is currently not yet recruiting. Last updated 22 April 2024.

Last reviewed 2024-04-22 · How we verify

NCT06377397: SAUNA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

Not yet recruiting Phase 3 Last updated 22 April 2024

What this trial tests

Phase 3 trial testing Antibiotics in Sepsis in 1,500 participants. Not yet recruiting.

Timeline

15 April 2024

Primary endpoint
15 April 2027

14 April 2028

Quick facts

Lead sponsor	Indian Council of Medical Research
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,500
Start date	15 April 2024
Primary completion	15 April 2027
Estimated completion	14 April 2028
Sites	1 location across India

Drugs / interventions tested

Antibiotics — full drug profile →

Conditions studied

Sepsis — all drugs for Sepsis →
PROM, Preterm (Pregnancy) — all drugs for PROM, Preterm (Pregnancy) →
Early-Onset Neonatal Sepsis — all drugs for Early-Onset Neonatal Sepsis →
Preterm Premature Rupture of Membrane — all drugs for Preterm Premature Rupture of Membrane →

Sponsor

Indian Council of Medical Research

Who can join

Adults 0 Hours to 4 Hours, any sex, with Sepsis or PROM, Preterm (Pregnancy). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis. The goal of this research study is to find out: 1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life. 2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life. 3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes").

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Antibiotics

Trials testing the same drug.

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NCT05813184 — Prenatal Antibiotics and Breast Milk / Neonatal IgA · recruiting
NCT05502913 — Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer · Phase 2 · recruiting

Other recruiting trials for Sepsis

Currently open trials in the same condition.

NCT07507877 — Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness · recruiting
NCT07154615 — Assessing Immune Dysfunction in Sepsis · recruiting
NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
NCT07351344 — African Survey on Sepsis Knowledge (ASK) · recruiting
NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting

Other Indian Council of Medical Research trials

Trials by the same sponsor.

NCT03280147 — 7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06377397 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indian Council of Medical Research
Last refreshed: 22 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06377397.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing