Infant Severe Sepsis and Bacterial Meningitis in Malawi (Infaseme)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Elizabeth Molyneux, University of Malawi College of Medicine

ClinicalTrials.gov Identifier:

NCT01247909

First received: January 14, 2010

Last updated: January 15, 2014

Last verified: January 2014

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Health Facilities Meningitis Sepsis

Drug Information available for: Gentamicin Gentamicin sulfate Ceftriaxone Ceftriaxone sodium

Genetic and Rare Diseases Information Center resources: Bacterial Meningitis

U.S. FDA Resources

Further study details as provided by University of Malawi College of Medicine:

Primary Outcome Measures:

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 ]

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. [ 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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247909

Locations


Malawi
Queen Elizabeth Central Hospital/ College of Medicne
Private Bag 360 Blantyre, Malawi, 3

Sponsors and Collaborators

University of Malawi College of Medicine

Investigators


Principal Investigator:	Elizabeth Molyneux, FRCPCH	Malawi College of Medicine, Paediatrics Department

More Information

No publications provided


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 Meningitis, Bacterial Bacterial Infections Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Nervous System Diseases Ceftriaxone	Gentamicins Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Synthesis Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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