Infant Severe Sepsis and Bacterial Meningitis in Malawi (Infaseme)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant Bacterial Meningitis |
Drug: Ceftriaxone v penicillin and gentamicin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Randomised Trial of Ceftriaxone v Penicillin and Gentamicin in Infant Severe Sepsis and Bacterial Meningitis in Malawi |
- 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 ]
- 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 ]
| Estimated Enrollment: | 238 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ceftriaxone v penicillin and gentamicin
Ceftriaxone (one arm) v penicillin and gentamicin (second arm) in the treatment of infant 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.
|
Eligibility| Ages Eligible for Study: | up to 2 Months (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01247909
| Malawi | |
| Queen Elizabeth Central Hospital/ College of Medicne | |
| Private Bag 360 Blantyre, Malawi, 3 | |
| Principal Investigator: | Elizabeth Molyneux, FRCPCH | Malawi College of Medicine, Paediatrics Department |
More Information
| Responsible Party: | Elizabeth Molyneux, Professor of Paediatircs, University of Malawi College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01247909 History of Changes |
| Other Study ID Numbers: | Infaseme |
| Study First Received: | January 14, 2010 |
| Last Updated: | January 15, 2014 |
| Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
Additional relevant MeSH terms:
|
Meningitis Sepsis Meningitis, Bacterial Central Nervous System Diseases Nervous System Diseases Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Central Nervous System Bacterial Infections |
Bacterial Infections Central Nervous System Infections Penicillins Gentamicins Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016