RecruitingPhase 3

Efficacy of INM004 in Children With STEC-HUS

Argentina220 participantsStarted 2024-10-05

Plain-language summary

The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).

Who can participate

Age range9 Months – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 9 months and \< 18 years at the time of randomization.
✓. In addition, only for subjects \< 1 year and ≥ 15 years, confirmation of STEC infection determined by:
✓. Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stools by enzyme immunoassay (EIA); or
✓. Detection of stx, stx1, stx2, or stx1/stx2 genes in stools by Polymerase Chain Reaction (PCR); or
✓. Detection of specific anti-polysaccharide (IgM) antibodies in serum; or
✓. Fecal culture positive for E. coli O157 confirmed by serogroup-specific seroagglutination.
✓. Hospitalization at the participating institution.
✓. History of onset of diarrhea within 10 days prior to STEC-HUS diagnosis at the participating institution.

Exclusion criteria

✕. Start of dialysis within 48 hours prior to admission to the participating institution.
✕. More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
✕. History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
✕. Personal and/or family history of atypical HUS.
✕. Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).
✕. Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders).
✕. Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the efficacy and/or safety of the study medication.
✕. History of: a) anaphylaxis of any kind; b) prior administration of equine serum (e.g., antivenom, anti-arachnid serum, anti-SARS-CoV-2 serum, etc.) or an allergic reaction from contact or exposure to horses.

What they're measuring

Time to recovery of renal function during the acute phase

Timeframe: 28 days

Trial details

NCT IDNCT06389474

SponsorInmunova S.A.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-30

Contact for this trial

Mariana Colonna, Bioch

+541120331455 mcolonna@inmunova.com

View on ClinicalTrials.gov More Hemolytic-Uremic Syndrome trials