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A Phase III study to evaluate the efficacy of INM004 (Shiga antitoxin) in pediatric patients with Shiga toxin-producing Escherichia coli-associated Hemolytic Uremic Syndrome.
EU CTIS ID: 2024-512412-22-00
What this study is testing
Evaluate the efficacy of INM004, added to the SoC, in the amelioration of renal involvement.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: a. Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stool by enzyme immunoassay (EIA); or b. Detection of stx, stx1, stx2, or stx1/stx2 genes in stool by Polymerase Chain Reaction (PCR); or c. Detection of specific anti-lipopolysaccharide (IgM) antibodies in whole blood or serum; or d. 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 the clinical diagnosis of STEC-HUS at the participating institution.
- Clinical diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis and platelet consumption 1: a. Signs of renal damage defined as: - Serum creatinine value above the ULN for age and sex 2,3, and GFR below the LLN for age, sex and height. b. Presence of hemolysis documented by: - LDH levels above the ULN for age, and/or - Presence of schistocytes in peripheral blood smear. c. Platelet consumption according to any of the following laboratory criteria: - Peripheral blood platelet count < 150 × 103/μl, and/or - A ≥50% decrease in peripheral blood platelet count compared to a sample collected within the previous 24 hours.
- Informed consent form signed and dated by the subject or, (the legal guardian(s), with the subject's assent as appropriate based on age and regulatory guidelines of the region.
You likely can't join if
- Start of dialysis within 48 hours prior to admission to the participating institution.
- Impossibility of hospitalization in the participating institution.
- Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.
- Severe malnutrition. Defined when the weight is three standard deviations below the median, according to height, age and sex as per WHO guidelines
- Known medical conditions that may affect kidney function or cause/enhance neurological symptoms or signs such as: • Congenital or acquired structural anomalies of the urinary tract. • Epilepsy or structural abnormalities of the brain that may increase the risk of seizures. • Trisomy 21. • Prematurity (born before 28 weeks of gestation). • Other (according to the Investigator criteria)
- More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
See the full eligibility criteria
Who can join
- 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: a. Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stool by enzyme immunoassay (EIA); or b. Detection of stx, stx1, stx2, or stx1/stx2 genes in stool by Polymerase Chain Reaction (PCR); or c. Detection of specific anti-lipopolysaccharide (IgM) antibodies in whole blood or serum; or d. 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 the clinical diagnosis of STEC-HUS at the participating institution.
- Clinical diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis and platelet consumption 1: a. Signs of renal damage defined as: - Serum creatinine value above the ULN for age and sex 2,3, and GFR below the LLN for age, sex and height. b. Presence of hemolysis documented by: - LDH levels above the ULN for age, and/or - Presence of schistocytes in peripheral blood smear. c. Platelet consumption according to any of the following laboratory criteria: - Peripheral blood platelet count < 150 × 103/μl, and/or - A ≥50% decrease in peripheral blood platelet count compared to a sample collected within the previous 24 hours.
- Informed consent form signed and dated by the subject or, (the legal guardian(s), with the subject's assent as appropriate based on age and regulatory guidelines of the region.
- Subjects who have already had menarche (WOCBP) must have a negative highly sensitive urine or serum pregnancy test
What rules you out
- Start of dialysis within 48 hours prior to admission to the participating institution.
- Impossibility of hospitalization in the participating institution.
- Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.
- Severe malnutrition. Defined when the weight is three standard deviations below the median, according to height, age and sex as per WHO guidelines
- Known medical conditions that may affect kidney function or cause/enhance neurological symptoms or signs such as: • Congenital or acquired structural anomalies of the urinary tract. • Epilepsy or structural abnormalities of the brain that may increase the risk of seizures. • Trisomy 21. • Prematurity (born before 28 weeks of gestation). • Other (according to the Investigator criteria)
- 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 (such as acute infections, diabetes, liver disease requiring medical treatment, etc.)
- 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.
- Pregnant or breastfeeding woman.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.