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Infant Severe Sepsis and Bacterial Meningitis in Malawi (Infaseme)

Primary Purpose

Infant Bacterial Meningitis

Status
Completed
Phase
Phase 4
Locations
Malawi
Study Type
Interventional
Intervention
Ceftriaxone v penicillin and gentamicin
Sponsored by
Kamuzu University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant Bacterial Meningitis

Eligibility Criteria

undefined - 2 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth Central Hospital/ College of Medicne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftriaxone

Penicillin and gentamicin

Arm Description

Ceftriaxone in infants with sepsis and bacterial meningitis

Penicillin and Gentamicin in infants with sepsis and bacterial meningitis

Outcomes

Primary Outcome Measures

Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.

Secondary Outcome Measures

Outcome by causative bacterial agent, recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.

Full Information

First Posted
January 14, 2010
Last Updated
October 24, 2016
Sponsor
Kamuzu University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01247909
Brief Title
Infant Severe Sepsis and Bacterial Meningitis in Malawi
Acronym
Infaseme
Official Title
An Open Randomised Trial of Ceftriaxone v Penicillin and Gentamicin in Infant Severe Sepsis and Bacterial Meningitis in Malawi
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kamuzu University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Bacterial Meningitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftriaxone
Arm Type
Experimental
Arm Description
Ceftriaxone in infants with sepsis and bacterial meningitis
Arm Title
Penicillin and gentamicin
Arm Type
Active Comparator
Arm Description
Penicillin and Gentamicin in infants with sepsis and bacterial meningitis
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone v penicillin and gentamicin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Molyneux, FRCPCH
Organizational Affiliation
Malawi College of Medicine, Paediatrics Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Central Hospital/ College of Medicne
City
Private Bag 360 Blantyre
ZIP/Postal Code
3
Country
Malawi

12. IPD Sharing Statement

Learn more about this trial

Infant Severe Sepsis and Bacterial Meningitis in Malawi

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