Can a pill replace an IV for Drug-Resistant shigella in children?
NCT ID NCT05121974
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests whether an oral antibiotic called tebipenem-pivoxil works as well as the standard IV antibiotic ceftriaxone for children with shigellosis, a severe diarrheal disease, when first-line treatment fails. The study enrolls children aged 24 to 59 months who have not improved after initial therapy. Participants receive either tebipenem-pivoxil by mouth or ceftriaxone by injection for three days, and researchers track clinical and microbiologic outcomes over 30 days. The goal is to see if the oral option can be a reliable alternative to the more resource-intensive IV treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tebipenem-pivoxil, an oral antibiotic, compared to intravenous ceftriaxone
- What this could lead to
- If it works, this could offer a simpler, oral alternative to IV ceftriaxone for children with drug-resistant shigellosis, reducing the need for hospital-based injections.
- What could go wrong
- This is a phase 2 trial with a small number of participants, so results may not hold up in larger studies. The drug may not match ceftriaxone's effectiveness, and antibiotic resistance remains a concern.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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132 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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24 to 59 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212, Bangladesh
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