A clinical trial to compare the role of 14 days vs 21 days iv antibiotic in neonates with uncomplicated meningitis.

Comparison of efficacy of 14 days vs 21 days course of iv antibiotics in the treatment of uncomplicated neonatal meningitis:A non inferiority Randomised controlled trial.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053614

Enrollment

210

Registered

2023-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G009- Bacterial meningitis, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: 14 days antibiotic course,ampicillin plus cefotaxime or ampicillin plus Aminoglycoside: 14 days antibiotic course ,ampicillin (50mg/kg/dose 8hourly) plus cefotax

Eligibility

Inclusion criteria

Inclusion criteria: CSF proven Neonatal Meningitis

Exclusion criteria

Exclusion criteria: 1.Presence of lethal chromosome abnormalities 2.Presence of severe congenital anomalies 3.Known immunodeficiency state 4.Symptomatic system congenital viral infection 5.Significant bleeding diathesis 6.Major intracranial bleed

Design outcomes

Primary

Measure	Time frame
1.To compare the mortality or readmission of neonates with meningitis being treated with 14days vs 21 days antibiotic course in first 3 months of age. 2.To look for recurrence of seizures or any complication for example ventriculitis, brain abscess, cerebral oedema, raised intracranial pressure, subdural empyema, hydrocephalus, infarct & sinus venous thrombosis post discharge from nicu.Timepoint: 3 months	—

Measure

Time frame

1.To compare the mortality or readmission of neonates with meningitis being treated with 14days vs 21 days antibiotic course in first 3 months of age. 2.To look for recurrence of seizures or any complication for example ventriculitis, brain abscess, cerebral oedema, raised intracranial pressure, subdural empyema, hydrocephalus, infarct & sinus venous thrombosis post discharge from nicu.Timepoint: 3 months

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Secondary

Measure	Time frame
1.To cut off the unnecessary hospital stay in resource limited areas due to longer course of antibiotics 2.To decrease the development of antimicrobial resistance. 3.To prevent unwanted changes in flora form in NICU with optimal duration of empirical antibiotic . 4.To decrease complication related to increased duration of antibiotic treatment such as Necrotising enterocolitis etc. 5.Head circumference monitoring 6.Weight monitoring 7.Developmental milestones achievement status.Timepoint: 3 months	—

Measure

Time frame

1.To cut off the unnecessary hospital stay in resource limited areas due to longer course of antibiotics 2.To decrease the development of antimicrobial resistance. 3.To prevent unwanted changes in flora form in NICU with optimal duration of empirical antibiotic . 4.To decrease complication related to increased duration of antibiotic treatment such as Necrotising enterocolitis etc. 5.Head circumference monitoring 6.Weight monitoring 7.Developmental milestones achievement status.Timepoint: 3 months

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Countries

India

Contacts

Public ContactDr Swati Maurya

Moti Lal Nehru Medical College,Prayagraj

mukeshvirsingh@gmail.com9456630304

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026