Disease: Pertussis -Whooping Cough, (NCT04535505)

Disease info:

The bacterium Bordetella pertussis causes pertussis, an acute infectious disease. In the 20th century, pertussis was one of the most common childhood diseases and a major cause of U.S. childhood mortality. Since widespread use of the vaccine began, incidence has decreased more than 75% compared with the pre-vaccine era.

In 2012, the last peak year, CDC reported 48,277 cases of pertussis. However, CDC believes that much of the disease goes unrecognized and unreported.

Several factors have likely contributed to the increase in reported cases, including

  • Increased awareness and improved recognition of pertussis among clinicians
  • Greater access to and use of laboratory diagnostics, especially polymerase chain reaction (PCR) testing
  • Increased surveillance and reporting of pertussis to public health departments
  • Waning immunity from vaccines

Additionally, B. pertussis are also always changing at a genetic level. CDC continues to evaluate what impact, if any, molecular changes in B. pertussis are having on public health.

Pertussis is primarily a toxin-mediated disease. The bacteria

  • Attach to the cilia of the respiratory epithelial cells
  • Produce toxins that paralyze the cilia
  • Cause inflammation of the respiratory tract, which interferes with the clearing of pulmonary secretions

Until recently, scientists thought that B. pertussis did not invade the tissues. However, recent studies suggest that the bacteria are present in alveolar macrophages.

Before the availability of pertussis vaccine in the 1940s, public health experts reported more than 200,000 cases of pertussis annually. In 2012, the last peak year, CDC reported 48,277 cases of pertussis.
Official title:
Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes

Study Director: Chuanqing Wang, Phd Children's Hospital of Fudan University


China, Shanghai

Study start:
Oct. 12, 2020
Estimated 600 participants
Cross Primer Amplification using CRISPR-Cas

Status: Terminated


Pertussis is an acute respiratory infectious disease caused by bordetella pertussis. Although it is a vaccine-preventable disease, outbreaks and epidemic cases of whooping cough worldwide have been reported from time to time. Bordella parapertussis, Bodella bronchiseptica, and bordetella hosei can cause pertussis-like diseases with symptoms similar to those of whooping cough. The clinical manifestations are difficult to distinguish, and they are easily reported as cases of whooping cough through the infectious disease network.

The diagnosis of the infectious diseases caused by the four pathogenic bodella mainly relies on laboratory pathogenic testing. At present, the laboratory tests of bordetella that can be carried out in the clinical microbiology laboratory include culture, bordetella pertussis specific antibody (PT-IgG) serological detection, and bordetella pertussis nucleic acid PCR detection. However, none of them meet the requirements of early diagnosis.

Cross primer constant temperature amplification (CPA) is nucleic acid constant temperature amplification technology with independent property rights. The fully automated nucleic acid detection platform equipped with CPA technology would make the detection of four pathogenic bordetella easy, quick and safe and accurate.

As pathogenic bodella is difficult to cultivate and there is no standard for drug susceptibility test. Studies have shown that 57.4% of the isolated clinical isolates of bordetella pertussis have MIC value for erthomycin ≥256 μg/mL , and 23s rRNA 2047 site adenine (A) were mutated to guanine (G).CRISPR/Cas is an immune system in bacteria that can specifically recognize invading nucleic acids and shear them. The CRISPR technology developed based on the CRISPR/Cas principle can detect single point mutations in genes.

The hypothesis that 4 pathogenic bordetella and their erythromycin resistance would be detected in one testing platform simultaneously. The accuracy, reliability, predictive value of this platform would be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be as the gold standard method.

Last updated: Jan. 2, 2023
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