Real-time PCR detection of causative microorganisms in pediatric patients with acute otitis media in clinical phase III tebipenem-pivoxil studies

Kimiko Ubukuta, Miyuki Morozumi, Naoko Chiba, Keiko Hamano-Hasegawa

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

We used real-time PCR, together with conventional bacterial culture, to detect bacteria and viruses and heighten the accuracy of detecting causative microorganisms in Phase III clinical trials of tebipenempivoxil (TBPM-PI), an oral carbapenem antibiotic, in pediatric patients with acute otitis media(AOM). Of 399 subjects, 224 (56.1%) showed positive results in culture and real-time PCR. In 41 (10.3 %), pbp genes mediating β-lactam. resistance of Streptococcus pneumoniae and Haemophilus influenzae were identified by conventional PCR after real-time PCR, but cultivation was negative. In 47 (11.8%), no resistance genes were identified by conventional PCR even though real-time PCR was positive. In addition, 8 subjects (2.0%) were virus-positive. Isolates determined to be causative microorganisms were S. pneumoniae, with 117 isolates in 116 subjects; H. influenzae with 112 isolates; Streptococcus pyogenes in 8 subjects; Moraxella catarrhalis with 7 isolates, and Staphylococcus aureus with 2 isolates. Bacteria showing positive results alone in real-time PCR were mostly S. pneumoniae and H. influenzae. A high correlation (γ = 0.9369 to 0.9710) between the number of bacteria in culture and Ct value of the positive reaction in real-time PCR was noted in S. pneumoniae and H. influenzae. According to AOM guidelines published in 2006, severe cases are significantly more in whom organisms were isolated (P<0.0001). We concluded that real-time PCR use in clinical studies increases the accuracy of detecting causative microorganisms.

Original languageEnglish
Pages (from-to)49-57
Number of pages9
JournalJapanese Journal of Chemotherapy
Volume57
Issue numberSUPPL. 1
Publication statusPublished - 2009 Mar
Externally publishedYes

Fingerprint

Otitis Media
Real-Time Polymerase Chain Reaction
Pediatrics
Haemophilus influenzae
Streptococcus pneumoniae
Bacteria
Viruses
Moraxella (Branhamella) catarrhalis
Lactams
Polymerase Chain Reaction
Phase III Clinical Trials
Carbapenems
Streptococcus pyogenes
tebipenem
Genes
Staphylococcus aureus
Guidelines

Keywords

  • Acute otitis media
  • Causative organism
  • Child
  • Real-time PCR
  • Tebipenem pivoxil

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Real-time PCR detection of causative microorganisms in pediatric patients with acute otitis media in clinical phase III tebipenem-pivoxil studies. / Ubukuta, Kimiko; Morozumi, Miyuki; Chiba, Naoko; Hamano-Hasegawa, Keiko.

In: Japanese Journal of Chemotherapy, Vol. 57, No. SUPPL. 1, 03.2009, p. 49-57.

Research output: Contribution to journalArticle

Ubukuta, Kimiko ; Morozumi, Miyuki ; Chiba, Naoko ; Hamano-Hasegawa, Keiko. / Real-time PCR detection of causative microorganisms in pediatric patients with acute otitis media in clinical phase III tebipenem-pivoxil studies. In: Japanese Journal of Chemotherapy. 2009 ; Vol. 57, No. SUPPL. 1. pp. 49-57.
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