Bacterial InfectionPhase 3NCT00189384
Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants
A Phase 3 study testing ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin in people with Bacterial Infection and Sepsis, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Read more about this study
- Who is it for?
- Ages 0 years to 59 days
- Conditions the study is for
- Bacterial Infection, Sepsis, Infant, Newborn
- What is being tested?
- ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin
- Type of treatment
- Pill or oral medicine
- How many people
- 426 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2003to Dec 2005
- Phase
- Phase 3
- 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 0 years to 59 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-59 days presenting to Young Infant community study site
- Clinical diagnosis of possible serious bacterial infection by study physician according to specified clinical criteria
- Parents refuse to accept referral care and sign (or thumb imprint) document stating this.
- Parents consent to community centre-based intramuscular antibiotic injections
Who cannot join
- Age over 59 days
- Presence of severe jaundice diagnosed clinically or by laboratory investigation (bilirubin > 12 g/dl in term and > 7 in pre-term baby).
- Presence of obvious meningitis (bulging fontanelle, observed seizures)
- Patient previously enrolled in antibiotic therapy trial
- Parents accept hospital referral
- Parents do not consent to any injectable therapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Aga Khan University community field sites
Karachi, Sindh, 74800
About this study
Official title: Randomized Controlled Trial of Intramuscular Ceftriaxone Versus Procaine Penicillin Versus Cotrimoxazole and Gentamicin for Management of Serious Bacterial Infections in Young Infants in Community Settings
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside.However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport.
Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis.
This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting.
- Conditions
- Bacterial Infection, Sepsis, Infant, Newborn
- Being tested
- ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin
- Keywords
- Neonatal sepsis, Neonatal pneumonia, Bacterial infections, Young infants, Neonate, Community, Developing country
- Medical subject headings
- Bacterial Infections, Sepsis, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of success rate will be defined as patient cured or improved with the regimen assigned to, on day 7 of therapy.
Secondary outcomes (3)
Completion rates
Adverse events
Relapse rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 426 participants
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Anita KM Zaidi, MBBS, SM, Principal investigator, Department of Pediatrics, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189384
- Sponsor's protocol ID
- SC/SNL 11150-0902-50001-269
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Publications
Bang AT, Bang RA, Baitule SB, Reddy MH, Deshmukh MD. Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Lancet. 1999 Dec 4;354(9194):1955-61. doi: 10.1016/S0140-6736(99)03046-9.
PubMed 10622298Bang AT, Reddy HM, Deshmukh MD, Baitule SB, Bang RA. Neonatal and infant mortality in the ten years (1993 to 2003) of the Gadchiroli field trial: effect of home-based neonatal care. J Perinatol. 2005 Mar;25 Suppl 1:S92-107. doi: 10.1038/sj.jp.7211277.
PubMed 15791283Bang AT, Bang RA, Stoll BJ, Baitule SB, Reddy HM, Deshmukh MD. Is home-based diagnosis and treatment of neonatal sepsis feasible and effective? Seven years of intervention in the Gadchiroli field trial (1996 to 2003). J Perinatol. 2005 Mar;25 Suppl 1:S62-71. doi: 10.1038/sj.jp.7211273.
PubMed 15791280
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Intramuscular Ceftriaxone Versus Procaine Penicillin Versus Cotrimoxazole and Gentamicin for Management of Serious Bacterial Infections in Young Infants in Community Settings
- ClinicalTrials.gov ID
- NCT00189384
- Acronym / sponsor ID
- SC/SNL 11150-0902-50001-269
- Conditions
- Bacterial Infection, Sepsis, Infant, Newborn
- Keywords
- Neonatal sepsis, Neonatal pneumonia, Bacterial infections, Young infants, Neonate, Community, Developing country
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 426 participants
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- Dec 2005
- First posted
- 19 Sep 2005 (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.
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside.However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport.
Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis.
This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years to 59 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 0-59 days presenting to Young Infant community study site
- Clinical diagnosis of possible serious bacterial infection by study physician according to specified clinical criteria
- Parents refuse to accept referral care and sign (or thumb imprint) document stating this.
- Parents consent to community centre-based intramuscular antibiotic injections
Key exclusion criteria (6 listed)
- Age over 59 days
- Presence of severe jaundice diagnosed clinically or by laboratory investigation (bilirubin > 12 g/dl in term and > 7 in pre-term baby).
- Presence of obvious meningitis (bulging fontanelle, observed seizures)
- Patient previously enrolled in antibiotic therapy trial
- Parents accept hospital referral
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, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin | Drug | – |
Primary outcome
The primary outcome of success rate will be defined as patient cured or improved with the regimen assigned to, on day 7 of therapy.
3 secondary outcomes
Completion rates
Adverse events
Relapse rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
- Background: PubMed 10622298Bang AT, Bang RA, Baitule SB, Reddy MH, Deshmukh MD. Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Lancet. 1999 Dec 4;354(9194):1955-61. doi: 10.1016/S0140-6736(99)03046-9.
- Background: PubMed 15791283Bang AT, Reddy HM, Deshmukh MD, Baitule SB, Bang RA. Neonatal and infant mortality in the ten years (1993 to 2003) of the Gadchiroli field trial: effect of home-based neonatal care. J Perinatol. 2005 Mar;25 Suppl 1:S92-107. doi: 10.1038/sj.jp.7211277.
- Background: PubMed 15791280Bang AT, Bang RA, Stoll BJ, Baitule SB, Reddy HM, Deshmukh MD. Is home-based diagnosis and treatment of neonatal sepsis feasible and effective? Seven years of intervention in the Gadchiroli field trial (1996 to 2003). J Perinatol. 2005 Mar;25 Suppl 1:S62-71. doi: 10.1038/sj.jp.7211273.
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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.
Anita KM Zaidi, MBBS, SM principal investigator
Department of Pediatrics, Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin in people with Bacterial Infection and Sepsis, run by Aga Khan University at 1 site in Pakistan.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Sep 2006. 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 Pakistan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The primary outcome of success rate will be defined as patient cured or improved with the regimen assigned to, on day 7 of therapy.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00189384, which also lists 3 linked publications.
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 11 Sep 2006.