Effects of Viral and Bacterial Co-infections in Otherwise Healthy Children Hospitalized in Pediatric Department

NCT02325102 | Completed DMC

• 1 other identifier: HMC102-13
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Co-occurence of multiple pathogens in children is a known phenomenon, however the potential effect on the probability to develop a disease and on its severity, as well as the relationships between them, has not been studied adequately. In this study, children admitted to the pediatric department with a clinical presentation of an infectious disease were tested for the presence of multiple pathogens. Data about their clinical status and about the accessory examinations performed during hospitalization were collected and analyzed.

Conditions

Coinfection

Outcome Measures

Primary Outcomes (1)

• number of patients with co-infections

  Patients in whom 2 or more pathogens were found in culture, serology or other tests.

  2 years

Secondary Outcomes (1)

• Types and species of pathogens

  2 years

Other Outcomes (1)

• Inflammation indicators in lab results of each patient

  2 years

Interventions

No intervention OTHER

As this is an observational study, no intervention was conducted.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

otherwise healthy children admitted in pediatric department

You may qualify if:

• Currently or recently febrile, otherwise healthy children aged 0 to 17 years admitted at several medical centers (Hillel Yaffe, Bnai Zion) in Israel, who were found to have viral, bacterial or both infections.

You may not qualify if:

• Afebrile for more than 72 hours
• Chronic illness
• Immune compromised (due to immunosuppressive drugs, neoplastic disease, etc.)
• History of prematurity or IUGR
• Not fully vaccinated for age according to national routine vaccination program
• Infection not being the primary diagnosis
• Under antibiotic therapy:
• Currently receiving
• Recently received (less than 48 hours)
• No infection was documented during research period

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Related Publications (5)

• Randolph AG, Vaughn F, Sullivan R, Rubinson L, Thompson BT, Yoon G, Smoot E, Rice TW, Loftis LL, Helfaer M, Doctor A, Paden M, Flori H, Babbitt C, Graciano AL, Gedeit R, Sanders RC, Giuliano JS, Zimmerman J, Uyeki TM; Pediatric Acute Lung Injury and Sepsis Investigator's Network and the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Critically ill children during the 2009-2010 influenza pandemic in the United States. Pediatrics. 2011 Dec;128(6):e1450-8. doi: 10.1542/peds.2011-0774. Epub 2011 Nov 7.

  PMID: 22065262 BACKGROUND

• Thorburn K, Harigopal S, Reddy V, Taylor N, van Saene HK. High incidence of pulmonary bacterial co-infection in children with severe respiratory syncytial virus (RSV) bronchiolitis. Thorax. 2006 Jul;61(7):611-5. doi: 10.1136/thx.2005.048397. Epub 2006 Mar 14.

  PMID: 16537670 BACKGROUND

• Spurling GK, Fonseka K, Doust J, Del Mar C. Antibiotics for bronchiolitis in children. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005189. doi: 10.1002/14651858.CD005189.pub2.

  PMID: 17253545 BACKGROUND

• Levin D, Tribuzio M, Green-Wrzesinki T, Ames B, Radwan S, Jarvis JD, Vaccaro T, Modlin JF. Empiric antibiotics are justified for infants with respiratory syncytial virus lower respiratory tract infection presenting with respiratory failure: a prospective study and evidence review. Pediatr Crit Care Med. 2010 May;11(3):390-5. doi: 10.1097/PCC.0b013e3181b809c5.

  PMID: 19838143 BACKGROUND

• American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.

  PMID: 17015575 BACKGROUND

MeSH Terms

Conditions

Coinfection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Nitai A Levy, MD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 24, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 24, 2014

Record last verified: 2014-12