Infant Bacterial Meningitis Clinical Trial
— InfasemeOfficial title:
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.
| Status | Completed |
| Enrollment | 351 |
| Est. completion date | April 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 2 Months |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Malawi | Queen Elizabeth Central Hospital/ College of Medicne | Private Bag 360 Blantyre |
| Lead Sponsor | Collaborator |
|---|---|
| University of Malawi College of Medicine |
Malawi,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge. | 3 years | Yes | |
| Secondary | Outcome by causative bacterial agent, recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge. | 3 years | Yes |