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Infant Severe Sepsis and Bacterial Meningitis in Malawi

NCT ID: NCT01247909

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infant Bacterial Meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceftriaxone

Ceftriaxone in infants with sepsis and bacterial meningitis

Group Type EXPERIMENTAL

Ceftriaxone v penicillin and gentamicin

Intervention Type 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.

Penicillin and gentamicin

Penicillin and Gentamicin in infants with sepsis and bacterial meningitis

Group Type ACTIVE_COMPARATOR

Ceftriaxone v penicillin and gentamicin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kamuzu University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Molyneux

Professor of Paediatircs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Molyneux, FRCPCH

Role: PRINCIPAL_INVESTIGATOR

Malawi College of Medicine, Paediatrics Department

Locations

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Queen Elizabeth Central Hospital/ College of Medicne

Private Bag 360 Blantyre, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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Infaseme

Identifier Type: -

Identifier Source: org_study_id