O. Patey

Quality and Safety Requirements for Sustainable Phage Therapy Products

The worldwide antibiotic crisis has led to a renewed interest in phage therapy. Since time immemorial phages control bacterial populations on Earth. Potent lytic phages against bacterial pathogens can be isolated from the environment or selected from a collection in a matter of days. In addition, phages have the capacity to rapidly overcome bacterial resistances, which will inevitably emerge. To maximally exploit these advantage phages have over conventional drugs such as antibiotics, it is important that sustainable phage products are not submitted to the conventional long medicinal product development and licensing pathway. There is a need for an adapted framework, including realistic production and quality and safety requirements, that allowsa timely supplying of phage therapy products for ‘personalized therapy’ or for public health or medical emergencies. This paper enumerates all phage therapy product related quality and safety risks known to the authors, as well as the tests that can be performed to minimize these risks, only to the extent needed to protect the patients and to allow and advance responsible phage therapy and research.

A bacteriophage journey at the European Medicines Agency.

The seriously and globally increasing bacterial multi-drug resistance calls out on concerted counteractive measures: international health authorities give consideration to the therapeutical use of bacteriophage therapy.

A Rare Case of Cotrimoxazole-induced Eosinophilic Aseptic Meningitis in an HIV-infected Patient

A case of cotrimoxazole-induced meningoencephalitis in an HIV-infected patient without signs of AIDS is reported. The patient developed an apparently generalized seizure, of cotrimoxazole, 1 month after first taking a dose of this drug and a febrile coma after a second dose 3 weeks later. Lumbar puncture revealed eosinophilic aseptic meningitis. The patient quickly recovered without sequelae and was given antiretroviral therapy plus pentamidine aerosolized and pyrimethamine as prophylaxis for opportunistic infections. No other adverse effects were observed. The report describes the diagnosis of this case supported by a commentary, including a literature review.

Actualité de l’antibiothérapie inhalée dans les infections respiratoires à Pseudomonas aeruginosa

Resume L’antibiotherapie par voie inhalee dans le traitement des infections respiratoires a Pseudomonas aeruginosa a revolutionne la prise en charge therapeutique et l’evolution de la mucoviscidose. S’il existe, dans cette indication, des protocoles scientifiquement valides pour le traitement de la primo-colonisation et le traitement d’entretien de l’infection chronique, de nombreuses incertitudes demeurent. La place des antibiotiques inhales en traitement adjuvant des pneumopathies nosocomiales, dont Pseudomonas aeruginosa est dans un tiers des cas l’agent responsable, est mal definie. Les deux molecules les plus interessantes sont la colistine et la tobramycine. Ce sont des antipyocyaniques puissants, pour lesquelles les resistances sont rares. L’antibiotherapie inhalee a l’avantage d’etre denuee d’effets systemiques. La bonne tolerance, l’efficacite clinique prouvee, l’absence d’emergence de resistances et l’absence de cout supplementaire, font de l’antibiotherapie inhalee un atout therapeutique dans la prise en charge des infections respiratoires a Pseudomonas aeruginosa .

Comité de lutte contre la grippe et la pandémie 2009 : retour d’expérience

The Committee for the Prevention and Control of Influenza (Comité de lutte contre la Grippe - CLCG) is an advisory committee to the French Health Minister for a medical and scientific collective expertise on the measures to be implemented to control or to reduce the impact of an epidemic or a pandemic of influenza. Appointed by decree, the CLCG consists of ex-officio members; representatives of French Agencies strongly involved by influenza and qualified personalities, representing various fields of expertise. Collective expertise is based on consensus after thorough collective discussion. A notice is drafted in reply to every official question and passed on either to the Chief Medical Officer, or, when the question concerns vaccines, to the Technical Committee of the vaccinations for which the CLCG acted as a working group. The CLCG was extremely active throughout the pandemic. The objective of this article is to describe in a factual way its output throughout this period of sanitary crisis. This article presents and compare chronologically and in a factual way the state of the scientific knowledge about influenza due to the A(H1N1)pdm09 virus and the CLCG notices. Between the alert launched by the WHO the 24th of April and the 31st of December 2009, CLCG met on 40 occasions. Its work dealt in particular with patient care, recommendations on medical treatment (antivirals, seasonal and pandemic vaccines), and on virological diagnosis. Whatever the defects of its expertise delivered in a context of urgency, which was a difficult exercise, the CLCG fulfilled its advisory to the health authorities. However, the pandemic experience showed that this expertise must be improved by insuring the recognition and the visibility of the advisory committee and by defining their exact position in the chain of decision.