Infant Severe Sepsis and Bacterial Meningitis in Malawi | NCT01247909

Studies
Infant Severe Sepsis and Bacterial Meningitis in Malawi

NCT01247909

Sponsor

Kamuzu University of Health Sciences

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

351Actual

Phase

Phase 4

Conditions

Infant Bacterial Meningitis

Interventions

Ceftriaxone v penicillin and gentamicin

Countries

Malawi

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Feb 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Nov 24, 2010

First Posted Date

Nov 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth Molyneux, Professor of Paediatircs, Kamuzu University of Health SciencesPrincipal Investigator

Lead Sponsor

Kamuzu University of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

351Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ceftriaxone	Experimental	Ceftriaxone in infants with sepsis and bacterial meningitis	Drug: Ceftriaxone v penicillin and gentamicin
Penicillin and gentamicin	Active Comparator	Penicillin and Gentamicin in infants with sepsis and bacterial meningitis	Drug: Ceftriaxone v penicillin and gentamicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftriaxone v penicillin and gentamicin	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.		3 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth Molyneux, FRCPCH	Malawi College of Medicine, Paediatrics Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Elizabeth Central Hospital/ College of Medicne		Private Bag 360 Blantyre		3	Malawi

Intervention Browse Module

MeSH Terms

ID	Term
D005839	Gentamicins

Ancestor Terms

ID	Term
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates

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