NCT03494959 (PENTALLO) is a Phase 2 clinical trial of Pentaglobin in Septic Shock, sponsored by Gruppo Italiano Trapianto di Midollo Osseo.

Who is sponsoring NCT03494959?

NCT03494959 is sponsored by Gruppo Italiano Trapianto di Midollo Osseo.

What drugs are being tested in NCT03494959?

Interventions in NCT03494959: Pentaglobin.

What condition does NCT03494959 study?

NCT03494959 studies Septic Shock.

Is NCT03494959 still recruiting?

NCT03494959 is currently active, enrolled. Last updated 6 January 2025.

Last reviewed 2025-01-06 · How we verify

NCT03494959: PENTALLO

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

Pentaglobin in CRE and PA Neutropenic Infections

Active, enrolled Phase 2 Last updated 6 January 2025

What this trial tests

Phase 2 trial testing Pentaglobin in Septic Shock in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 December 2019

Primary endpoint
31 May 2024

31 May 2025

Quick facts

Lead sponsor	Gruppo Italiano Trapianto di Midollo Osseo
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	6 December 2019
Primary completion	31 May 2024
Estimated completion	31 May 2025
Sites	20 locations across Italy

Drugs / interventions tested

Pentaglobin — full drug profile →

Conditions studied

Septic Shock — all drugs for Septic Shock →

Sponsor

Gruppo Italiano Trapianto di Midollo Osseo — full company profile →

Who can join

18 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by carbapenem-resistant Enterobacteriaceae or by any Pseudomonas aeruginosa.

Publications & conference data

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

Anti-<i>Pseudomonas aeruginosa</i> Vaccines and Therapies: An Assessment of Clinical Trials.
Elmassry MM, Colmer-Hamood JA, Kopel J, San Francisco MJ, et al · · 2023 · cited 27× · PMID 37110338 · DOI 10.3390/microorganisms11040916
Healthcare-Associated Infections: The Role of Microbial and Environmental Factors in Infection Control-A Narrative Review.
Sandu AM, Chifiriuc MC, Vrancianu CO, Cristian RE, et al · · 2025 · cited 11× · PMID 40208412 · DOI 10.1007/s40121-025-01143-0

Verify or expand the search:

Other trials of Pentaglobin

Trials testing the same drug.

NCT04351724 — Austrian CoronaVirus Adaptive Clinical Trial (COVID-19) · Phase 2, PHASE3 · unknown

Other recruiting trials for Septic Shock

Currently open trials in the same condition.

NCT07179276 — Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock · NA · recruiting
NCT07383103 — Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock · Phase 4 · recruiting
NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
NCT07264543 — Early Methylene Blue in the Microhemodynamics of Septic Patients · Phase 2, PHASE3 · recruiting
NCT04855786 — External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients · NA · recruiting

Other Gruppo Italiano Trapianto di Midollo Osseo trials

Trials by the same sponsor.

NCT06790680 — GITMO AML/MDS-Relapse Registry Study · completed
NCT04506320 — Novel Drugs After Allo-HSCT in Patients With Multiple Myeloma · completed
NCT04412811 — Prospective Survey of CMV, Herpesviruses Infections and Diseases in Allo-HSCT · completed
NCT03270748 — Post Transplant High-Dose Cy as GvHD Prophylaxis in 1 HLA Mismatched Unrelated HSCT for Myeloid Malignancies · Phase 2 · completed
NCT04476199 — Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT · Phase 2 · active not recruiting

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 NCT03494959 (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 Gruppo Italiano Trapianto di Midollo Osseo
Last refreshed: 6 January 2025

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/NCT03494959.

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