[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of pidotimod granules in the adjuvant treatment of recurrent respiratory tract infections in children

评价匹多莫德颗粒辅助治疗儿童反复呼吸道感染的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of pidotimod granules as an adjunctive therapy for recurrent respiratory tract infections in children.

Start Date31 Aug 2023

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Co., Ltd.

NCT04322669 / CompletedPhase 4

Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)

The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.

Start Date04 Aug 2021

Sponsor / Collaborator

Almirall SA

CTR20191766 / CompletedPhase 4

一项匹多莫德用于儿童反复呼吸道感染 (RRI) 的随机、双盲、安慰剂对照临床试验

[Translation] A randomized, double-blind, placebo-controlled clinical trial of pidotimod for recurrent respiratory infections (RRI) in children

评估整个研究期间匹多莫德相较于安慰剂的有效性

[Translation]

To assess the effectiveness of pidotimod compared with placebo throughout the study period

Start Date13 Aug 2020

Sponsor / Collaborator

Doppel Farmaceutici SRL

[+2]

100 Clinical Results associated with Pidotimod

100 Translational Medicine associated with Pidotimod

100 Patents (Medical) associated with Pidotimod

135

Literatures (Medical) associated with Pidotimod

01 Aug 2024·Chirality

Tandem Mass Spectrometry Approaches for Differentiation and Quantification Pidotimod and Its Three Isomers in the Gas Phase

Article

Author: Zhang, Caiyu ; He, Lan ; Li, Wei ; Liu, Yang

ABSTRACTPidotimod is a chiral drug that possesses two chiral centers, resulting in three isomeric impurities (analytes, A). This study employs electrospray ionization ion trap mass spectrometry (ESI‐MS) through collision‐induced dissociation (CID) to investigate the chiral recognition of pidotimod and its three isomers to eliminate chromatographic separation. Three approaches were explored: (1) Protonated molecules in CID exhibited discriminative potential for diastereomers, with the ability to distinguish between S,S and R,R configurations, albeit with an Rchiral value of ~1.8. However, differentiation between R,S and S,R configurations was not achievable. (2) Alkali adductions (lithium and sodium) only discerned diastereomers. The Rchiral values of the diastereomers obtained from alkali adduct ions were significantly lower than those obtained from protonated ions. (3) Therefore, a third approach was used to address the challenge of distinguishing between R,S and S,R configurations, including the introduction of chiral references (ref) and transition metals (MII) to form metal‐bound complexes [MII(A)(ref)‐H]+. Additionally, we synthesized a novel ligand, 4‐(N‐tert‐butoxycarbonyl [Boc]‐L‐prolinamido)phenol (denoted as ligand A), by modifying N‐t‐Boc‐L‐Pro with 2‐aminophenol, which, in combination with CuII and NiII, enabled simultaneous differentiation of all four isomers. CuII complexes exhibited significant chiral selectivity between R,S and S,R configurations. Density functional theory calculations were performed to further elucidate the stereodynamic behavior and stoichiometry of these ions in the gas phase. These calculations revealed the interaction energy and coordination sites of the precursor ions in the gas phase, correlating well with MS/MS experiment results. Additionally, the logarithm of the CuII complexes' characteristic fragment ion abundance ratio demonstrated a strong linear relationship with enantiomeric excess (ee). This study presents a novel strategy for chiral drug quality control that eliminates chromatographic separation.

12 Apr 2024·Alternative therapies in health and medicine

Analysis of Factors and T-Lymphocyte Subset Changes in Pediatric Recurrent Respiratory Infections Post-Pidotimod Treatment.

Article

Author: Jin, Chong ; Wang, Yaodong ; Guo, Yan ; Chen, Yinyin ; Hu, Renmin ; Lin, Xiang

ObjectiveThis study aims to analyze factors contributing to recurrent respiratory tract infections (RRTIs) in pediatric patients and evaluate the efficacy of pidotimod (PI) treatment.MethodsThis study utilized a retrospective cohort design, enrolling a total of 85 children diagnosed with RRTIs between September 2020 and September 2022, alongside 54 healthy children. Logistic regression analysis was employed to identify factors contributing to RRTI occurrence. Among the participants, 40 children underwent conventional treatment (control group), while 45 received PI treatment (research group). Comparative analyses were conducted to assess clinical efficacy and adverse effects between the two treatment groups.ResultsThe history of family members' smoking and parental allergy emerged as independent risk factors for RRTIs (P < .05, OR>1), whereas parental education level, outdoor activity, and micronutrient intake were identified as independent protective factors for RRTIs (P < .05, OR<1). Symptoms such as cough, fever, rhonchi, moist rales, and tonsillar enlargement resolved significantly faster in the research group compared to the control group (P < .05). Additionally, the research group exhibited reduced infection duration and fewer recurrent infections (P < .05). Following treatment, the overall treatment efficacy was superior in the research group compared to the control group (P < .05), with no significant difference in the incidence of adverse effects (P > .05). Post-treatment, levels of CD3+, CD4+, and CD4+/CD8+ were elevated in the research group compared to the control group, while CD8+ levels were lower (P < .05).ConclusionsDaily outdoor activity among children, family members' history of smoking, parental allergy history, education level, and micronutrient intake emerged as independent factors influencing pediatric RRTIs. Furthermore, PI was identified as a significant treatment option for RRTIs.

01 Aug 2023·Heliyon

Application of immunomodulatory therapy in a human brucellosis patient with pancytopenia: A case report

Author: Zhao, Leheng ; Dang, Sheng ; Zhai, Jingbo ; Zhang, Guoqing ; Zhang, Shuai ; Wu, Liankui

Brucellosis is a common zoonotic infectious disease with diverse and non-specific clinical manifestations caused by Brucella. Although Brucella can cause damage to multiple systems in the human body, hematological complications are relatively rare. We present a case of a 47-year-old male brucellosis patient with pancytopenia. In May 2018, the patient was diagnosed with brucellosis and recovered after receiving antibiotic treatment (rifampicin 600 mg/day and doxycycline 200 mg/day) for six weeks. However, after three years, the patient experienced a recurring high fever. Brucellosis relapse was confirmed based on the patient's clinical history, Rose Bengal plate agglutination test and standard tube agglutination test results. Routine blood examination revealed a decrease in the whole blood cell count, suggesting bone marrow suppression. Bone marrow aspiration and bacterial culture confirmed the diagnosis of brucellosis with pancytopenia. Antibiotic treatment failed to effectively improve the patient's condition. Therefore, a combination of immunomodulatory and antibiotic treatments was used. The antibiotic regimen included oral rifampicin 600 mg/day, intravenous doxycycline hydrochloride 200 mg/day, and subcutaneous injection of human granulocyte-stimulating factor (0.2 mg/day). Immunomodulatory therapy consisted of 20,000 mg/day intravenous human immunoglobulin (pH 4) for five days and 800 mg/day oral pidotimod liquid for 20 days. As the treatment progressed, the count gradually recovered to normal levels, and the symptoms of bone marrow suppression were alleviated. PCR testing revealed the absence of Brucella DNA in both monocyte and serum samples. Furthermore, negative standard tube agglutination test results were obtained. These findings indicate that the immunomodulatory therapy resulted in a complete clearance of Brucella. Therefore, immunomodulatory therapy could be an effective option in cases of brucellosis with pancytopenia that are unresponsive to conventional antibiotic treatment. Further research and clinical evidence are required to confirm and optimize the use of immunomodulatory therapies in patients with brucellosis.

News (Medical) associated with Pidotimod

27 Feb 2021

·www.globenewswire.com

Ovation Fertility Releases Preliminary Findings of Ongoing Non-Invasive PGT-A Study

Los Angeles, Feb. 28, 2021 (GLOBE NEWSWIRE) -- Ovation® Fertility’s Genetics program has released the initial findings of its ongoing study of non-invasive preimplantation genetic testing for aneuploidy (PGT-A). PGT-A is used to identify chromosomally normal embryos for transfer, increasing the chances of a successful pregnancy from IVF. Among Ovation’s key findings to date: Amplification parameters and time in single drop culture are directly related to concordance with trophectoderm biopsy PGT-A results. The study began in November 2020 and will continue on an ongoing basis, with more findings being released publicly as additional data become available. Today, most PGT-A is performed invasively, with embryologists performing an embryo biopsy to remove individual cells from an embryo’s trophectoderm to be sent a specialized genetics laboratory for chromosomal testing, yielding a high degree of certainty in the results. This study examines the efficacy of an alternative, non-invasive form of testing, which uses cell-free DNA sourced from the culture media in which an embryo is growing in the IVF laboratory after fertilization and prior to freezing or transfer. Embryos in this study are tested both via biopsy and non-invasively, and the results of both tests are compared to determine their degree of concordance. Non-invasive PGT-A has long been considered a promising technology, however, results of studies have been sporadic, with some producing unreliable results or low concordance with results from highly reliable PGT-A methods. Challenges in these studies have arisen from the small volume of embryo culture media, collection and handling of spent media, and validation of non-invasive PGT-A results, with the true karyotype of the embryos tested being uncertain. By using the data from this study to improve protocols for sample collection and use of alternative DNA amplification technologies, Ovation is generating solid data and evidence-based best practices for non-invasive PGT-A to advance the state of the art in genetic testing of embryos. “So far, these data are proving what we have long suspected: The longer the amount of time an embryo spends in culture media, the higher the level of concordance with results from invasive PGT-A,” says Amy Jones, MS, ELD (ABB), scientific director of Ovation Genetics. “Similarly, the starting quantity of cell-free DNA also has an impact on concordance. Small changes at each step of the process can impact the quality of the results. While our study is not complete, it is important for physicians to understand that non-invasive PGT-A may not yield the same high level of certainty as invasive PGT-A, but can still be a valuable and more cost-effective tool when more information about embryo quality is needed prior to embryo transfer.” The study is expected to continue for several months, and includes Ovation partner fertility practices as well as clients of Ovation Genetics laboratories. For information about joining the study, fertility specialists or IVF laboratory directors can contact Jones at AJones@OvationFertility.com. Learn more about Ovation Genetics at . About Ovation Fertility Ovation® Fertility is a national network of reproductive endocrinologists and scientific thought leaders focused on reducing the cost of having a family through more efficient and effective fertility care. Ovation’s IVF and genetics laboratories, along with affiliated physician practices, work collaboratively to raise the bar for IVF treatment, with state-of-the-art, evidence-based fertility services that give hopeful parents the best chance for a successful pregnancy. Physicians partner with Ovation to offer their patients advanced preconception carrier screening; preimplantation genetic testing; donor egg and surrogacy services; and secure storage for their frozen eggs, embryos and sperm. Ovation also helps IVF labs across America improve their quality and performance with expert off-site lab direction and consultation. Learn more about Ovation’s vision of a world without infertility at . Attachment Amy Hall Ovation Fertility 214-893-8214 AHall@OvationFertility.com

06 Sep 2017

·www.bioportfolio.com

Yungjin Pharm Co Ltd 003520 Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 22082017] Prices from USD $250

Summary Yungjin Pharm Co Ltd Yungjin, a subsidiary of KTG Corp is a pharmaceutical company that develops, manufactures and distributes active pharmaceutical ingredients, formulations and tonic drinks. The company's API products include cephalosporins and other general products. It also provides cefaclor cap and dry syr, cefadroxil monohydrate, cefalexin monohydrate, cefamandole inj, cefcapene pivoxil tab and fine gran, cefmetazole inj, cefminox inj, cefotaxime inj, and cefatrizine propylene glycolate, among others. Yungjin offers formulation products for various therapeutic areas such as antibiotics, CNS, cardiovascular, endocrine system, respiratory, antiinflammatory and analgesics, antihistamine, antifungal, total nutrition, urinary system, vitamin and supplement, and cosmetics. The company also provides tonic drinks with pidotimod liquid. It operates through research and development institute, and factory located in Korea. Yungjin is headquartered in Seoul, South Korea. Yungjin Pharm Co Ltd 003520 Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

Acquisition

100 Deals associated with Pidotimod

External Link

KEGG	Wiki	ATC	Drug Bank
D07261	Pidotimod	L03AX05	DB11364

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Tract Infections	CN	Sunstone (Tangshan) Pharmaceutical Co., Ltd.	01 Jan 2001
Urinary Tract Infections	CN	Sunstone (Tangshan) Pharmaceutical Co., Ltd.	01 Jan 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Infections	Phase 2	CN	Shenyang Shuangding Pharmaceutical Co., Ltd.	09 Nov 2014
Pulmonary Disease, Chronic Obstructive	Phase 2	CN	Shenyang Shuangding Pharmaceutical Co., Ltd.	09 Nov 2014
Brain Infarction	Phase 2	CN	-	25 Oct 2013
Bronchitis	Phase 1	CN	-	29 Oct 2013
Gynecological infection	Discovery	CN	Shenyang Shuangding Pharmaceutical Co., Ltd.	21 Nov 2013
Lower Respiratory Tract Infections	Discovery	CN	Shenyang Shuangding Pharmaceutical Co., Ltd.	21 Nov 2013
Otitis Media	Discovery	CN	Shenyang Shuangding Pharmaceutical Co., Ltd.	21 Nov 2013
Urinary Tract Infections	Discovery	CN	Shenyang Shuangding Pharmaceutical Co., Ltd.	21 Nov 2013
Bronchitis	Discovery	CN	Harbin Changxinxin Pharmaceutical Research Institute	29 Oct 2013
Bronchitis	Discovery	CN	Heilongjiang Jiangshi Medicine Industry Co. Ltd.	29 Oct 2013

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