This is a multicentre, observational, epidemiological study in which infants within the first 3 months of life with UTI and children aged ≥4 months with r-UTI will be recruited from nephrology /emergency departments and primary care in European countries

开始日期2025-01-01

申办/合作机构

Penta Global Blockchain Foundation, Inc.

NCT05993442 / Not yet recruitingN/A

Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in Neonatal Intensive Care: a Pragmatic, Multicentre, Parallel Cluster Randomised Hybrid Implementation-effectiveness Study.

NeoDeco is a pragmatic, multicenter, parallel group, cluster randomised hybrid effectiveness-implementation study with baseline assessment, wash-in period and staggered randomisation. All sites will be offered the implementation support for optimised Kangaroo Care (KC) as part of the study; however, intervention sites will be randomised to immediate receipt of implementation support whereas standard care sites will be offered this after the study period.

开始日期2024-02-01

申办/合作机构

Penta Global Blockchain Foundation, Inc.

[+5]

NCT05965427 / RecruitingN/AIIT

Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV

This data collection study aims to describe and compare the outcomes of Mpox on people living with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP). The study also aims to identify risk factors for specific Mpox outcomes.

开始日期2023-12-01

申办/合作机构

NEAT ID Foundation

[+1]

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2023-06-01·Journal of Pediatric Gastroenterology & Nutrition

Inadequate Hospital Practices to Prevent Mother-to-Child Transmission of Hepatitis B Virus Infection: A European Survey

Article

作者: Rocchi, Francesca ; Giaquinto, Carlo ; Pinon, Michele ; Calvo, Pier Luigi ; Cananzi, Mara ; Giugliano, Laura ; Wade, Barbara ; Auriti, Cinzia ; Indolfi, Giuseppe

Objectives:Prevention of vertical transmission of hepatitis B virus (HBV) infection is crucial to eliminate viral hepatitis as a major public health threat by 2030. We aimed to assess the current hospital policies and practices implemented before, at, and after birth, and to evaluate potential barriers to the full application of international guidelines.Methods:A web-based survey was supported by PENTA Foundation and distributed across Europe from October to December 2021.Results:Overall, 76 centers with delivery departments completed the survey. Hepatitis B surface antigen (HBsAg) maternal screening is performed in the first trimester of pregnancy in 53% of the centers and in the third in 46%. HBsAg positive pregnant women are tested for serologic HBV markers and HBV-DNA in 78% and 63% of the departments; 38% of the HBeAg positive women with high HBV-DNA levels are treated during the last trimester of pregnancy. At birth, 91% of the departments administer HBV vaccine to infants born to HBsAg positive mothers within 12 hours of birth; 74% test women with unknown HBsAg status and 78% of them wait for the maternal testing results before administering HBV vaccine to their newborns. After birth, 47% of the departments provide postvaccination serological testing for infants born to HBsAg positive mothers. The timing of the HBV vaccine schedule varies greatly.Conclusions:There is significant heterogeneity in the hospital policies and correlated procedures. The implementation of a multidisciplinary clinical pathway is a must if a stronger connection between the prenatal, perinatal, and postnatal phases is to be established.

2021-12-30·New England Journal of Medicine1区 · 医学

Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children

1区 · 医学

Article

作者: Bbuye, Dickson ; Variava, Ebrahim ; Ngampiyaskul, Chaiwat ; Bwakura-Dangarembizi, Mutsa ; Lugemwa, Abbas ; Ramsagar, Nastassja ; Kobbe, Robin ; Musoke, Philippa ; Musiime, Victor ; Violari, Avy ; Rojo, Pablo ; Liberty, Afaaf ; Bernays, Sarah ; Amuge, Pauline ; Cotton, Mark F ; Musoro, Godfrey ; Kaudha, Elizabeth ; Makumbi, Shafic ; Klein, Nigel ; Chalermpantmetagul, Suwalai ; Gibb, Diana M ; Turkova, Anna ; Mujuru, Hilda A ; Kityo, Cissy M ; Sarfati, Tatiana ; Kekitiinwa, Adeodata R ; Saïdi, Yacine ; Ali, Shabinah ; Ahimbisibwe, Grace M ; Shakeshaft, Clare ; Behuhuma, Osee ; Colbers, Angela ; Atwine, Lorna ; Grossele, Tiziana ; Cressey, Tim R ; Coelho, Alexandra ; Giaquinto, Carlo ; Barlow-Mosha, Linda ; White, Ellen ; Archary, Moherndran ; Compagnucci, Alexandra ; Wynne, Ben ; Puthanakit, Thanyawee ; Ford, Deborah ; Welch, Steven B

BACKGROUNDChildren with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).METHODSWe conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method. Safety was assessed.RESULTSFrom September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor-based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, -0.08; 95% confidence interval, -0.14 to -0.03; P = 0.004). Treatment effects were similar with first- and second-line therapies (P = 0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P = 0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P = 0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P = 0.01).CONCLUSIONSIn this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127; EUDRACT number, 2014-002632-14; and ISRCTN number, ISRCTN91737921.).

2021-12-01·Pediatric Infectious Disease Journal4区 · 医学

Effective and Safe Daclatasvir Drug Exposures Predicted in Children Using Adult Formulations

4区 · 医学

Article

作者: Lallemant, Marc ; Easterbrook, Philippa ; El-Sayed, Manal H ; Al-Nahari, Mogeb ; Abbassi, Maggie ; Farid, Samar ; Penazzato, Martina ; Indolfi, Giuseppe ; Cressey, Tim R

Background:Sofosbuvir (SOF)/daclatasvir (DCV) is the direct-acting antiviral regimen of choice in many low- and middle-income countries for curative treatment of chronic hepatitis C virus (HCV) infection in adults, but data on the use of DCV in children are lacking. We performed a population pharmacokinetic (PK) analysis to predict DCV exposure in children treated with available adult formulations.Methods:DCV concentration data from HCV-infected adolescents receiving SOF/DCV [400/60 mg, once daily (OD)] who participated in a PK study in Egypt were used for model development. PK parameters were estimated using a population approach. Monte Carlo simulations were run for virtual children weighing 10 to <35 kg receiving 60 or 30 mg OD, and DCV exposures were compared with adults ranges.Results:Seventeen HCV-infected adolescents (13 males) provided 151 DCV concentrations. Median (range) age was 14 (11–18) years and weight 50 (32–63) kg. In these adolescents receiving 60 mg DCV, median (interquartile range) DCV area under the concentration time curve 0 to 24 hours, maximum concentrations, and minimum concentrations were 11,130 (8140–14,690) ng·h/mL, 1030 (790–1220) ng/mL and 130 (110–220) ng/mL, respectively, compared with 10,343 (7661–14,095) ng·h/mL, 1132 (876–1518) ng/mL and 110 (55.7–192) ng/mL predicted in children 10 to <35 kg receiving 30 mg. The proportion of children with DCV exposures above the adult range rapidly increased for children <30 kg using 60 mg OD, similarly for children 10–14 kg using 30 mg.Conclusions:DCV 30 mg OD was predicted to achieve effective and safe exposures in children 14 to <35 kg, perhaps down to 10 kg. These results should be validated clinically. Low-cost available adult DCV formulations together with approved pediatric doses of SOF would expand global access to HCV treatment for children.

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