A Phase 4 interventional study of Ceftriaxone v penicillin and gentamicin in Infant Bacterial Meningitis, sponsored by Kamuzu University of Health Sciences. Completed at 1 site in Malawi. Open to participants aged Up to 2 Months. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by Kamuzu University of Health Sciences · Phase 4, Interventional, and Treatment
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.
Kamuzu University of Health Sciences is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Ceftriaxone in infants with sepsis and bacterial meningitis
Drug: Ceftriaxone v penicillin and gentamicin
Penicillin and Gentamicin in infants with sepsis and 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.
Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.
Time frame: 3 years
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
The record gives a start of Apr 2010, a primary completion of Feb 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Kamuzu University of Health Sciences