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Completed

NCT Number: NCT01247909

Infant Severe Sepsis and Bacterial Meningitis in Malawi

This study aims to improve the outcome of infants (<2 months) with severe sepsis and meningitis at the Queen Elizabeth Central Hospital, Blantyre, Malawi.

Currently WHO recommends the treatment of infant severe sepsis and bacterial meningitis with 14 to 21 day course of penicillin and gentamicin as first line. The second line treatment is cefotaxime or ceftriaxone.

Severe bacterial infections are common in infants under 2 months of age and the mortality is very high (~50%). There are several reasons for this; one is that the first line antibiotics used are no longer as effective as they used to be. Bacterial resistance to the first line antibiotics has increased and some infections especially of the central nervous system may only be partly treated and not eradicated by present therapy. First line treatment is cheap and available but requires 4 injections a day, for at least 14 days, a total of 58 injections. Many mothers find this number too much and abscond. The investigators second line therapy is ceftriaxone which is also available and cheap and the advantage of being given as a daily injection. The disadvantage is that it can cause (reversible) jaundice particularly in premature babies and it must not be given with calcium products. The investigators do not give calcium to the investigators infants as the investigators cannot routinely check electrolytes. All the most common causes of bacterial meningitis in this age group in the investigators setting are sensitive to ceftriaxone.

The investigators wish to undertake an open randomized trial of penicillin and gentamicin v ceftriaxone as first line treatment for infant meningitis. The investigators are able to monitor for side effects.

The investigators hypothesise that the ceftriaxone arm will have 20% less deaths that the penicillin and gentamicin group.

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Key information

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen Elizabeth Central Hospital/ College of Medicne

Private Bag 360 Blantyre, 3, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children less than 2 months
  • Suspicion of bacterial meningitis
  • Parental/guardian informed consent

Exclusion criteria

  • Infant with hyperbilirubinaemia
  • Infant requiring calcium
  • Infant know to be hypersensitive to any of the three drugs
  • Infant who has been an inpatient for more than 72 hours
  • Infant with congenital central nervous system abnormalities

Treatment and study plan

Ceftriaxone v penicillin and gentamicin

Drug

Ceftriaxone v the standard treatment of infant meningitis (penicillin and gentamicin). Ceftriaxone will be given at a dose of 80mg/kg once a day for at least 14 days.

Primary outcomes

  1. Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.

    Time frame: 3 years

Secondary outcomes

  1. Outcome by causative bacterial agent, recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Kamuzu University of Health Sciences

Other

Registry information

Official study title

An Open Randomised Trial of Ceftriaxone v Penicillin and Gentamicin in Infant Severe Sepsis and Bacterial Meningitis in Malawi

Acronym: Infaseme

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2010
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.