Infant Bacterial MeningitisPhase 4InfasemeNCT01247909
Infant Severe Sepsis and Bacterial Meningitis in Malawi
A Phase 4 study testing Ceftriaxone v penicillin and gentamicin in people with Infant Bacterial Meningitis, run by Kamuzu University of Health Sciences at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Infant Bacterial Meningitis
- What is being tested?
- Ceftriaxone v penicillin and gentamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteMalawi
- Study dates
- Apr 2010to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than 2 months
- Suspicion of bacterial meningitis
- Parental/guardian informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Queen Elizabeth Central Hospital/ College of Medicne
Private Bag 360 Blantyre, 3
About this study
Official title: An Open Randomised Trial of Ceftriaxone v Penicillin and Gentamicin in Infant Severe Sepsis and Bacterial Meningitis in Malawi
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.
Read more
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.
- Conditions
- Infant Bacterial Meningitis
- Being tested
- Ceftriaxone v penicillin and gentamicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone v penicillin and gentamicinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone | Experimental | Ceftriaxone in infants with sepsis and bacterial meningitis Receives: Drug: Ceftriaxone v penicillin and gentamicin |
| Penicillin and gentamicin | Active comparator | Penicillin and Gentamicin in infants with sepsis and bacterial meningitis Receives: Drug: Ceftriaxone v penicillin and gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.
Measured: 3 years
Secondary outcomes (1)
Outcome by causative bacterial agent, recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Bacterial MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamuzu University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Molyneux, Kamuzu University of Health Sciences
- Investigators
- Elizabeth Molyneux, FRCPCH, Principal investigator, Malawi College of Medicine, Paediatrics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247909
- Sponsor's protocol ID
- Infaseme
- Acronym
- Infaseme
- Status last verified
- Oct 2016
- First submitted
- 14 Jan 2010
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomised Trial of Ceftriaxone v Penicillin and Gentamicin in Infant Severe Sepsis and Bacterial Meningitis in Malawi
- ClinicalTrials.gov ID
- NCT01247909
- Acronym / sponsor ID
- Infaseme / Infaseme
- Conditions
- Infant Bacterial Meningitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Kamuzu University of Health SciencesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone | Experimental | Drug: Ceftriaxone v penicillin and gentamicinCeftriaxone in infants with sepsis and bacterial meningitis |
| Penicillin and gentamicin | Active comparator | Drug: Ceftriaxone v penicillin and gentamicinPenicillin and Gentamicin in infants with sepsis and bacterial meningitis |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children less than 2 months
- Suspicion of bacterial meningitis
- Parental/guardian informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftriaxone v penicillin and gentamicinCeftriaxone 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. | Drug | Ceftriaxone, Penicillin and gentamicin |
Primary outcome
Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge.
Time frame: 3 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Molyneux, FRCPCH principal investigator
Malawi College of Medicine, Paediatrics Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone v penicillin and gentamicin in people with Infant Bacterial Meningitis, run by Kamuzu University of Health Sciences at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery v death or severe residual neurological sequelae at hospital discharge, 1 month and 6 months post discharge. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.