NCT03721302 is a clinical trial of Main study clinical sepsis in Neonatal SEPSIS, sponsored by Drugs for Neglected Diseases.

Who is sponsoring NCT03721302?

NCT03721302 is sponsored by Drugs for Neglected Diseases.

What drugs are being tested in NCT03721302?

Interventions in NCT03721302: Main study clinical sepsis, Microbiology sub study.

What condition does NCT03721302 study?

NCT03721302 studies Neonatal SEPSIS.

Is NCT03721302 still recruiting?

NCT03721302 is currently completed. Last updated 19 August 2020.

Last reviewed 2020-08-19 · How we verify

NCT03721302

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

NeoAMR Observational Study in Neonatal Sepsis

Completed Last updated 19 August 2020

What this trial tests

trial testing Main study clinical sepsis in Neonatal SEPSIS in 3,202 participants. Completed in 29 February 2020.

Timeline

16 August 2018

Primary endpoint
31 December 2019

29 February 2020

Quick facts

Lead sponsor	Drugs for Neglected Diseases
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,202
Start date	16 August 2018
Primary completion	31 December 2019
Estimated completion	29 February 2020
Sites	19 locations across Italy, South Africa, Greece, Uganda, Vietnam, Thailand, China, Bangladesh

Drugs / interventions tested

Main study clinical sepsis
Microbiology sub study

Conditions studied

Neonatal SEPSIS — all drugs for Neonatal SEPSIS →

Sponsor

Drugs for Neglected Diseases — full company profile →

Who can join

Under 60 Days, any sex, with Neonatal SEPSIS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Patterns of antibiotic use, pathogens, and prediction of mortality in hospitalized neonates and young infants with sepsis: A global neonatal sepsis observational cohort study (NeoOBS).
Russell NJ, Stöhr W, Plakkal N, Cook A, et al · · 2023 · cited 127× · PMID 37289666 · DOI 10.1371/journal.pmed.1004179
Neonatal invasive candidiasis in low- and middle-income countries: Data from the NeoOBS study.
Cook A, Ferreras-Antolin L, Adhisivam B, Ballot D, et al · · 2023 · cited 40× · PMID 36881725 · DOI 10.1093/mmy/myad010
Carveol Attenuates Seizure Severity and Neuroinflammation in Pentylenetetrazole-Kindled Epileptic Rats by Regulating the Nrf2 Signaling Pathway.
Alvi AM, Al Kury LT, Alattar A, Ullah I, et al · · 2021 · cited 31× · PMID 34422216 · DOI 10.1155/2021/9966663
IV and oral fosfomycin pharmacokinetics in neonates with suspected clinical sepsis.
Kane Z, Gastine S, Obiero C, Williams P, et al · · 2021 · cited 22× · PMID 33855449 · DOI 10.1093/jac/dkab083
Assessment of three antibiotic combination regimens against Gram-negative bacteria causing neonatal sepsis in low- and middle-income countries.
Kakaraskoska Boceska B, Vilken T, Xavier BB, Kostyanev T, et al · · 2024 · cited 16× · PMID 38729951 · DOI 10.1038/s41467-024-48296-z
Randomised controlled trial of fosfomycin in neonatal sepsis: pharmacokinetics and safety in relation to sodium overload.
Obiero CW, Williams P, Murunga S, Thitiri J, et al · · 2022 · cited 15× · PMID 35078765 · DOI 10.1136/archdischild-2021-322483
1,3,4, Oxadiazole Compound A3 Provides Robust Protection Against PTZ-Induced Neuroinflammation and Oxidative Stress by Regulating Nrf2-Pathway.
Alvi AM, Shah FA, Muhammad AJ, Feng J, et al · · 2021 · cited 10× · PMID 35002275 · DOI 10.2147/jir.s333451
Ibrutinib Delays ALS Installation and Increases Survival of SOD1G93A Mice by Modulating PI3K/mTOR/Akt Signaling.
Zheng C, Li W, Ali T, Peng Z, et al · · 2023 · cited 9× · PMID 37326908 · DOI 10.1007/s11481-023-10068-9

Verify or expand the search:

Other recruiting trials for Neonatal SEPSIS

Currently open trials in the same condition.

NCT03291496 — Microfluidic Assessment of Clinical Outcomes in Preterm Newborns · active not recruiting

Other Drugs for Neglected Diseases trials

Trials by the same sponsor.

NCT06997159 — A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefos · Phase 2 · not yet recruiting
NCT06512714 — Mycetoma Retrospective Data Collection · recruiting
NCT06356974 — Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT) · Phase 3 · not yet recruiting
NCT05957978 — LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study · Phase 2 · completed
NCT05947604 — DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan · Phase 1 · 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 NCT03721302 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Drugs for Neglected Diseases
Last refreshed: 19 August 2020

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/NCT03721302.

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