Infant Severe Sepsis and Bacterial Meningitis in Malawi (Infaseme)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Molyneux, University of Malawi College of Medicine
ClinicalTrials.gov Identifier:
NCT01247909
First received: January 14, 2010
Last updated: January 15, 2014
Last verified: January 2014

January 14, 2010
January 15, 2014
April 2010
February 2015   (final data collection date for primary outcome measure)
Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01247909 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Infant Severe Sepsis and Bacterial Meningitis in Malawi
An Open Randomised Trial of Ceftriaxone v Penicillin and Gentamicin in 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infant Bacterial Meningitis
Drug: Ceftriaxone v penicillin and gentamicin
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.
Experimental: Ceftriaxone v penicillin and gentamicin
Ceftriaxone (one arm) v penicillin and gentamicin (second arm) in the treatment of infant meningitis
Intervention: Drug: Ceftriaxone v penicillin and gentamicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
238
April 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
up to 2 Months
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01247909
Infaseme
Yes
Elizabeth Molyneux, University of Malawi College of Medicine
University of Malawi College of Medicine
Not Provided
Principal Investigator: Elizabeth Molyneux, FRCPCH Malawi College of Medicine, Paediatrics Department
University of Malawi College of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP