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Ampicillin + gentamicin or cefotaxime + gentamicin
This combination regimen uses two or three antibiotics with different mechanisms to provide broad-spectrum coverage against gram-positive, gram-negative, and anaerobic bacteria.
This combination regimen uses two or three antibiotics with different mechanisms to provide broad-spectrum coverage against gram-positive, gram-negative, and anaerobic bacteria. Used for Neonatal sepsis and serious bacterial infections in newborns, Empiric treatment of suspected gram-positive and gram-negative bacterial infections in pediatric populations.
At a glance
| Generic name | Ampicillin + gentamicin or cefotaxime + gentamicin |
|---|---|
| Also known as | Ampicillin sodium, Gentamicin sulphate, Cefotaxime sodium |
| Sponsor | PENTA Foundation |
| Drug class | Antibiotic combination (beta-lactam + aminoglycoside) |
| Target | Bacterial cell wall (beta-lactams) and bacterial ribosome (aminoglycoside) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Ampicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis. Gentamicin is an aminoglycoside that inhibits bacterial protein synthesis. Cefotaxime is a third-generation cephalosporin that also inhibits cell wall synthesis. The combination provides synergistic activity and broader coverage than monotherapy, particularly useful in serious infections where empiric coverage is needed before culture results are available.
Approved indications
- Neonatal sepsis and serious bacterial infections in newborns
- Empiric treatment of suspected gram-positive and gram-negative bacterial infections in pediatric populations
Common side effects
- Nephrotoxicity (aminoglycoside-related)
- Ototoxicity (aminoglycoside-related)
- Allergic reactions (beta-lactam-related)
- Diarrhea
- Elevated liver enzymes
Key clinical trials
- Aminoglycosides in Early Sepsis (PHASE4)
- Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (PHASE3)
- Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care (PHASE4)
- A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia (PHASE3)
- Antibiotic "Dysbiosis" in Preterm Infants (PHASE2)
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
- Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens (PHASE4)
- First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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