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

19 grudnia 2014 zaktualizowane przez: Hillel Yaffe Medical Center

Potential Clinical and Biological Effects of Viral and Bacterial Co-infections in Otherwise Healthy Children in Pediatric Department

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Introduction The relationship between viral and bacterial infections in the respiratory tract in children has long been learnt and documented in the medical literature. A large scale American study which was held during the "swine flu" (influenza A H1N1) pandemic in 2009-2010 documented pneumonia (or other pulmonary infection) of bacterial source in one third of the patients admitted to intensive care units (PICU - Pediatric Intensive Care Unit) [1]. Similar data and even higher incidence rates also exist for bronchiolitis caused by RSV (respiratory syncytial virus) [2]. These and similar studies raise questions about the real need for antibiotic treatment and whether it is being judiciously prescribed (as it turned out, for example, that there are places in the world where 30-90% of the viral bronchiolitis cases are treated with antibiotics [3]), which puts the patient at risk for side effects and potentially increases bacterial resistance. Moreover, one cannot ignore the fact that otherwise healthy children and children with comorbidity (such as chronic carrier state or relevant background disease) are not always being addressed separately in these studies. Despite all this, there is consensus that children with respiratory viral disease, mainly one that requires hospitalization in PICU, will benefit from empirical antibiotic treatment [4, 5]. On the other hand, when it comes to the potential impact of antiviral treatment on the course of a pulmonary bacterial disease during infection with influenza virus, the results are not encouraging, but the seasonal vaccination plays a key role in reducing the above morbidity [6]. As to whether the presence of a viral infection at the same time affects the severity of pulmonary bacterial infection (i.e. The disease is more serious than that of a viral origin only), there is evidence demonstrating an increase in mortality, duration of mechanical ventilation and duration of hospitalization in mixed bacterial and viral disease [7]. Several studies found and isolated some viruses of different types in the same respiratory ailment, but unanimity as to whether there is correlation between the number of viruses and the severity of the disease is missing [8, 9].

In addition to the multiplicity of sources dealing with the link between viral and bacterial respiratory infections, especially influenza and RSV, there is recent evidence in the literature of a viral-bacterial etiology in acute otitis media [10, 11], but so far a limited number of works has been made about the same relationship of other viruses or in other systems.

The goals of this article:

  1. To determine whether the data available in the context of mixed infections in respiratory diseases (see above) are also valid for diseases in other body systems.
  2. To discover whether the relationship between viral and bacterial infection is as strong as in the respiratory system
  3. to study the impact of the co-infection on morbidity (severity, length of stay, complications)
  4. to link between specific infection and its common mixed pathogens
  5. to specify age sections, gender, demographic characteristics, clinical condition, at which co-infections (and relevant consequences) predominate

Methods The study group comprised 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. Exclusion criteria are listed below (Table 1).

When a child meeting the above criteria was admitted, parent (or child's legal custodian) were given verbal and written explanation by a clinical investigator, signed an informed consent and approved him to collect blood samples and nasal or rectal swab. In accordance to the clinical presentation, additional tests were performed and included blood, urine and stool cultures and some viral and bacterial serologies.

For each patient, individual history was taken; presenting symptoms, physical examinations and lab results were documented; and additional data such as antibiotic therapy, length of stay and complications were collected during hospitalization by authorized medical staff using standard techniques and methods.

Specimen sampling:

  • Nasal swab
  • Blood sampling with CBC and chemistry tubes
  • Rectal swab (only in case of diarrhea)

Laboratory procedures:

Specimens were immediately placed in a refrigerator at 4°C, transferred to MeMed laboratory no longer than 5 hours following sampling.

In the laboratory, blood tests included CBC, bacterial and viral PCR incl. ELISA.

Although clinical signs were usually documented in a great detail, this method is problematic and prone bias for the purpose of defining infection, owing to the investigator's individual interpretation. Thus, in this study only microbiological definitions were used. Viral infection was defined as PCR positive for viral genome or as the presence of IgM antibody against viral specific antigen.

Bacterial infection required PCR positive for bacterial genome sequence, or colony counts 105 cfu/ml of diagnostic sample for each single species obtained, or the presence of IgM antibody against bacterial specific.

Data analysis:

All of the above information was transferred to and arranged in a designated database developed and maintained by the sub-investigators.

In the database, the investigators applied the exclusion criteria, found all patients with viral and bacterial co-infections and analyzed the investigated variants.

Table 1: Exclusion Criteria 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

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

400

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Nie starszy niż 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

otherwise healthy children admitted in pediatric department

Opis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
number of patients with co-infections
Ramy czasowe: 2 years
Patients in whom 2 or more pathogens were found in culture, serology or other tests.
2 years

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Types and species of pathogens
Ramy czasowe: 2 years
2 years

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Inflammation indicators in lab results of each patient
Ramy czasowe: 2 years
WBC count and differential, CRP, ESR
2 years

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Nitai A Levy, MD, Physician

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 czerwca 2014

Zakończenie podstawowe (Rzeczywisty)

1 września 2014

Ukończenie studiów (Rzeczywisty)

1 grudnia 2014

Daty rejestracji na studia

Pierwszy przesłany

2 grudnia 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 grudnia 2014

Pierwszy wysłany (Oszacować)

24 grudnia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

24 grudnia 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 grudnia 2014

Ostatnia weryfikacja

1 grudnia 2014

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HMC102-13

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