Neonatal SepsisNCT05742477
Treatment Outcome With Antibiotic Use and Its Resistance Pattern Among Patient With Neonatal Sepsis
An observational study of Neonatal Sepsis, run by Assiut University.
Trial summary
Determine Treatment outcome with antibiotic use and its resistance pattern among neonatal sepsis patients Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Antibiotic
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2023to 31 Dec 2024
- Phase
- Observational
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: patients with neonatal sepsis
Who may be able to join
- Newborn suspected with sepsis diagnosed on the basis of clinical signs and symptoms:
- temperature instability
- feeding problems,
- convulsions,
- lethargy
- respiratory distress.
Show all 10Show fewer
- laboratory findings such as:
- C-Reactive Protein (CRP)
- complete blood count (CBC)
- blood/urine cultures
Who cannot join
- Respiratory distress syndrome
- Congenital pneumonia
Trial locations and contacts
No sites are listed yet.
About this study
Determine Treatment outcome with antibiotic use and its resistance pattern among neonatal sepsis patients
Read the detailed description
Neonatal sepsis is a clinical syndrome characterized by systemic signs and symptoms of infection and is accompanied by bacteremia in the first month of life. Early-onset sepsis (EOS) is defined as sepsis occurring in the first 72 h of life and that occurring beyond 72 h is defined as late-onset sepsis (LOS). As per World Health Organization (WHO), neonatal sepsis is the third most frequent etiology of neonatal mortality. In the year 2013, a systematic analysis of global, national, and regional causes of child mortality found neonatal sepsis to be the leading cause of neonatal deaths in Europe. The National Neonatal Perinatal Database network (NNPD, 2002-03) comprising 18 tertiary care neonatal units across Europe reported sepsis (septicemia/meningitis) as the commonest cause of neonatal mortality, causing 23.4% of all neonatal deaths. The pattern of the bacterial pathogens responsible for neonatal sepsis has changed temporally and geographically. There is a difference in the causative organisms for neonatal sepsis between developed and developing countries. As per NNPD, Klebsiella pneumonia and Staphylococcus aureus are the commonest causative organisms for EOS and LOS in Europe. On the contrary, data from developed countries shows that gram-positive organisms are the predominant causes of EOS as well as LOS. The ability of bacteria to resist or to become tolerant to several structurally and functionally distinct drugs simultaneously is known as multidrug resistance. Simpler definitions quote "multidrug-resistant organisms (MDROs) are labeled as such because of their in-vitro resistance to more than one antimicrobial agent". On the other hand, definitions vary per specific organism. It is estimated that in Europe, 56,524 neonatal deaths each year are attributed to isolates resistant to first-line antibiotics. A recent point prevalence study - Antibiotic Resistance and Prescribing in European Children (ARPEC) was conducted in 226 hospitals (41 countries) which. This survey showed that most commonly used regimen for neonatal sepsis was a combination of ampicillin/amoxicillin/benzylpenicillin Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 3 and aminoglycoside. It further reported that 40% of pathogens isolated were resistant to first-line antibiotics prescribed by WHO. Though this survey had a paucity of data from low- and middle-income countries (LMICs), it provided important insights into the emergence of antibiotic resistance. Resistance to first-line antibiotics in different WHO regions Estimates of MDRO burden have also been reported from other countries. In a systematic review of five countries in South Asia (India, Pakistan, Sri Lanka, Bangladesh, and Nepal) comprising 109 studies, a high proportion of MDRO was reported. The pooled estimated data from hospitals and communities showed that Klebsiella pneumonia, E. coli, and Acinetobacter baumannii were multidrug resistant in 70.7%, 54%, and 78.7% of isolates respectively. A retrospective single-center study from Jordan evaluated 4 y data of 68 episodes of culture-positive neonatal sepsis. Gram-negative organisms were the commonest and 69% of these were multidrug resistant. In another cohort study from Taiwan, conducted over 8 y, 1106 episodes of culture-positive sepsis were reported. Of these, one-third were caused by gram-negative bacilli and 70 (18.6%) were multidrug resistant. A meta-analysis of 71 studies reported from China showed that 50% of gram-negative organisms were resistant to third-generation cephalosporins. Early signs of neonatal sepsis are : Diminished spontaneous activity Less vigorous sucking Anorexia Apnea Bradycardia Temperature instability (hypothermia or hyperthermia) Fever is present in only 10 to 15% of neonates but, when sustained (eg, > 1 hour), generally indicates infection. Other symptoms and signs include respiratory distress, neurologic findings (eg, seizures,itteriness), jaundice (especially occurring within the first 24 hours of life without Rh or ABO blood group incompatibility and with a higher than expected direct bilirubin concentration), vomiting, diarrhea, and abdominal distention. Periumbilical erythema, discharge, or bleeding without a hemorrhagic diathesis suggests omphalitis Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 4 (infection prevents obliteration of the umbilical vessels). Coma, seizures, opisthotonos, or a bulging fontanelle suggests meningitis, encephalitis, or brain abscess.
Decreased spontaneous movement of an extremity and swelling, warmth, erythema, or tenderness over a joint indicates osteomyelitis or pyogenic arthritis.
- Conditions
- Neonatal Sepsis
- Being tested
- Antibiotic
- Keywords
- neonatal, sepsis, antibiotics
- Medical subject headings
- Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
role of antibiotics in treatment of neonatal sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis convelence
It is difined by abcence of fever, jundice, respiratory failure and gastroentritis
Measured: 24hours
Sepsis convelence
It is difined by abcence of fever, jundice, respiratory failure and gastroentritis
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start31 Mar 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd elrahman Ahmed Hussain Abd eltwaab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742477
- Sponsor's protocol ID
- neonatal sepsis treatment
- Status last verified
- Feb 2023
- First submitted
- 22 Aug 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein JO. Bacteriology of neonatal sepsis. Pediatr Infect Dis J. 1990 Oct;9(10):778. No abstract available.
PubMed 2235163Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016 Dec 17;388(10063):3027-3035. doi: 10.1016/S0140-6736(16)31593-8. Epub 2016 Nov 11.
PubMed 27839855Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
PubMed 22579125Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.
PubMed 21518717
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome With Antibiotic Use and Its Resistance Pattern Among Patient With Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT05742477
- Acronym / sponsor ID
- neonatal sepsis treatment
- Conditions
- Neonatal Sepsis
- Keywords
- neonatal, sepsis, antibiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Feb 2023 (actual)
- 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.
Determine Treatment outcome with antibiotic use and its resistance pattern among neonatal sepsis patients
Detailed description
Neonatal sepsis is a clinical syndrome characterized by systemic signs and symptoms of infection and is accompanied by bacteremia in the first month of life. Early-onset sepsis (EOS) is defined as sepsis occurring in the first 72 h of life and that occurring beyond 72 h is defined as late-onset sepsis (LOS). As per World Health Organization (WHO), neonatal sepsis is the third most frequent etiology of neonatal mortality. In the year 2013, a systematic analysis of global, national, and regional causes of child mortality found neonatal sepsis to be the leading cause of neonatal deaths in Europe. The National Neonatal Perinatal Database network (NNPD, 2002-03) comprising 18 tertiary care neonatal units across Europe reported sepsis (septicemia/meningitis) as the commonest cause of neonatal mortality, causing 23.4% of all neonatal deaths. The pattern of the bacterial pathogens responsible for neonatal sepsis has changed temporally and geographically. There is a difference in the causative organisms for neonatal sepsis between developed and developing countries. As per NNPD, Klebsiella pneumonia and Staphylococcus aureus are the commonest causative organisms for EOS and LOS in Europe. On the contrary, data from developed countries shows that gram-positive organisms are the predominant causes of EOS as well as LOS. The ability of bacteria to resist or to become tolerant to several structurally and functionally distinct drugs simultaneously is known as multidrug resistance. Simpler definitions quote "multidrug-resistant organisms (MDROs) are labeled as such because of their in-vitro resistance to more than one antimicrobial agent". On the other hand, definitions vary per specific organism. It is estimated that in Europe, 56,524 neonatal deaths each year are attributed to isolates resistant to first-line antibiotics. A recent point prevalence study - Antibiotic Resistance and Prescribing in European Children (ARPEC) was conducted in 226 hospitals (41 countries) which. This survey showed that most commonly used regimen for neonatal sepsis was a combination of ampicillin/amoxicillin/benzylpenicillin Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 3 and aminoglycoside. It further reported that 40% of pathogens isolated were resistant to first-line antibiotics prescribed by WHO. Though this survey had a paucity of data from low- and middle-income countries (LMICs), it provided important insights into the emergence of antibiotic resistance. Resistance to first-line antibiotics in different WHO regions Estimates of MDRO burden have also been reported from other countries. In a systematic review of five countries in South Asia (India, Pakistan, Sri Lanka, Bangladesh, and Nepal) comprising 109 studies, a high proportion of MDRO was reported. The pooled estimated data from hospitals and communities showed that Klebsiella pneumonia, E. coli, and Acinetobacter baumannii were multidrug resistant in 70.7%, 54%, and 78.7% of isolates respectively. A retrospective single-center study from Jordan evaluated 4 y data of 68 episodes of culture-positive neonatal sepsis. Gram-negative organisms were the commonest and 69% of these were multidrug resistant. In another cohort study from Taiwan, conducted over 8 y, 1106 episodes of culture-positive sepsis were reported. Of these, one-third were caused by gram-negative bacilli and 70 (18.6%) were multidrug resistant. A meta-analysis of 71 studies reported from China showed that 50% of gram-negative organisms were resistant to third-generation cephalosporins. Early signs of neonatal sepsis are : Diminished spontaneous activity Less vigorous sucking Anorexia Apnea Bradycardia Temperature instability (hypothermia or hyperthermia) Fever is present in only 10 to 15% of neonates but, when sustained (eg, > 1 hour), generally indicates infection. Other symptoms and signs include respiratory distress, neurologic findings (eg, seizures,itteriness), jaundice (especially occurring within the first 24 hours of life without Rh or ABO blood group incompatibility and with a higher than expected direct bilirubin concentration), vomiting, diarrhea, and abdominal distention. Periumbilical erythema, discharge, or bleeding without a hemorrhagic diathesis suggests omphalitis Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 4 (infection prevents obliteration of the umbilical vessels). Coma, seizures, opisthotonos, or a bulging fontanelle suggests meningitis, encephalitis, or brain abscess.
Decreased spontaneous movement of an extremity and swelling, warmth, erythema, or tenderness over a joint indicates osteomyelitis or pyogenic arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with neonatal sepsis
Key inclusion criteria (10 listed)
- Newborn suspected with sepsis diagnosed on the basis of clinical signs and symptoms:
- temperature instability
- feeding problems,
- convulsions,
- lethargy
Key exclusion criteria (2 listed)
- Respiratory distress syndrome
- Congenital pneumonia
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 |
|---|---|---|
| Antibioticrole of antibiotics in treatment of neonatal sepsis | Drug | – |
Primary outcome
Sepsis convelence
Time frame: 24hours
It is difined by abcence of fever, jundice, respiratory failure and gastroentritis
Sepsis convelence
Time frame: 1 week
It is difined by abcence of fever, jundice, respiratory failure and gastroentritis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 2235163Klein JO. Bacteriology of neonatal sepsis. Pediatr Infect Dis J. 1990 Oct;9(10):778. No abstract available.
- Background: PubMed 27839855Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016 Dec 17;388(10063):3027-3035. doi: 10.1016/S0140-6736(16)31593-8. Epub 2016 Nov 11.
- Background: PubMed 22579125Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
- Background: PubMed 21518717Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.
- Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continuesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Neonatal Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
Chronic Granulomatous Disease, Infection
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
G-CSF In Neonatal Sepsis With Neutropenia
Neonatal Sepsis, Neutropenia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Sepsis, run by Assiut University.
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 10 inclusion and 2 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 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Abd elrahman Ahmed Hussain, resident doctor (0109326627 6, abduahmedh15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis convelence (time frame: 24hours). The study lists 2 primary outcomes in all. 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 NCT05742477, which also lists 4 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 24 Feb 2023.