Tebipenem treatment for children with Shigellosis
Tebipenem-pivoxil as an Alternative to Ceftriaxone for Clinically Non-responding Children With Shigellosis: a Randomized Non-inferiority Trial
This study is testing if a new antibiotic called tebipenem can effectively treat young children with Shigella infections compared to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 24 Months to 59 Months |
| Sex | All |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT05121974 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of tebipenem-pivoxil in treating children aged 24-59 months with suspected Shigella infections. The study is designed as a randomized non-inferiority trial comparing tebipenem-pivoxil to standard treatments like azithromycin and ceftriaxone. Given the rising antibiotic resistance in Shigella, this trial aims to provide an alternative treatment option that could be more effective for resistant strains. The trial will assess clinical outcomes and microbiological responses to the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 24-59 months presenting with clinical features of Shigella infection.
Not a fit: Patients who have received study antibiotics prior to presentation or have severe acute malnutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for children suffering from multidrug-resistant Shigella infections.
How similar studies have performed: Other studies have shown success with alternative antibiotic regimens for Shigella, but the specific use of tebipenem-pivoxil in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Children aged 24-59 months with suspected Shigella infection (clinical features of fever, mucus and/or blood in stools, tenesmus, and RBC and leucocytes \>10 per hpf) Exclusion Criteria: * Child received study antibiotics (azithromycin, ceftriaxone, and/or tebipenem) for the illness prior to presentation (as confirmed by bottle or prescription) * Severe acute malnutrition (SAM), defined as weight-for-height z-score less than -3 or mid-upper arm circumference less than 115mm, and/or other signs of infections requiring antibiotics * Patients with other infectious foci who are potentially unresponsive to treatment with orally administered medication * Patients in whom the efficacy and safety of the study drug is difficult to determine because of a progressive, complicated, or severe underlying disease believed to critically influence the onset of the infection, its clinical course, and therapeutic efficacy * Patients with convulsive disorders, such as epilepsy, as an underlying disease * Patients with a known lipid metabolism disorder or congenital carnitine deficiency * Patients with severe hepatic or renal dysfunction * Patients with a history of allergy to β-lactam antibiotics (e.g., carbapenems, penicillin, and cephems) * Patients who have received other antibiotics for the illness and exhibited improvements * Patients deemed inappropriate for this study by the attending physician * Clinically improved after first-line therapy * Unable to provide a stool sample at enrolment
Where this trial is running
Dhaka
- International Centre for Diarrhoeal Disease Research, Bangladesh — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Sharika Nuzhat, MBBS, DCH — International Centre for Diarrhoeal Disease Research, Bangladesh
- Study coordinator: M.A Salam Khan
- Email: salamk@icddrb.org
- Phone: +880-2-9827001-10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.