Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial

The MORDOR study, a masked, community-level randomized clinical trial conducted in Niger, Malawi and Tanzania (2015 to 2017), showed that biannual administration of single-dose azithromycin to preschool children reduced all-cause mortality. We sought to evaluate its impact on causes of death in children aged 1–59 months in Tanzania. A random sampling of 614 communities was conducted in Kilosa District, Tanzania, with simple random assignment of communities to receive either azithromycin or placebo. In these communities, a census was carried out every 6 months and children aged 1–59 months received biannual (every 6 months), single-dose azithromycin (~20mg/kg) or placebo depending on community assignment, over a 2-year period. Mortality was determined at the time of the biannual census. For child deaths, a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. A total of 190- (0.58 /100 person-years) and 200 deaths (0.59/100 person-years) were reported in the azithromycin and placebo arms, respectively. Malaria, pneumonia and diarrhea, accounted for 71% and 68% of deaths in the respective arms. Overall, the mortality was not different by treatment arm, nor were the distribution of causes of death after adjusting for community clustering. The cause-specific mortality for diarrhea/pneumonia was no different over time. In children aged 1–5 months, 32 deaths occurred in the placebo arm and 25 deaths occurred in the azithromycin arm; 20 (62.5%) deaths in the placebo- and 10 (40%) in the azithromycin arm were attributed to diarrhea or pneumonia. Neither differences in the number of deaths nor the diarrhea/pneumonia attribution was statistically significant after adjusting for community clustering. In conclusion, azithromycin was not associated with a significant decline in deaths by specific causes compared to placebo. The non-significant lower rates of diarrhea or pneumonia in children <6 months who received azithromycin merit further investigation in high-mortality settings. Trial registration: NCT02048007.

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Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽

10.1186/s12885-021-08197-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Safa Najafi ◽

Maryam Ansari ◽

Vahid Kaveh ◽

Shahpar Haghighat

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Single Dose ◽

Side Effects ◽

Randomized Clinical Trial ◽

Cancer Patients ◽

Injection Site Reaction ◽

Study Groups ◽

Breast Cancer Patients ◽

Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

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Single-dose effects of Citalopram on neural responses to affective stimuli in borderline personality disorder: A randomized clinical trial

Biological Psychiatry Cognitive Neuroscience and Neuroimaging ◽

10.1016/j.bpsc.2021.02.002 ◽

2021 ◽

Author(s):

Christian Paret ◽

Inga Niedtfeld ◽

Tobias Lotter ◽

Andreas Wunder ◽

Simone Grimm ◽

...

Keyword(s):

Clinical Trial ◽

Single Dose ◽

Borderline Personality Disorder ◽

Personality Disorder ◽

Randomized Clinical Trial ◽

Borderline Personality ◽

Neural Responses ◽

Affective Stimuli ◽

Dose Effects

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Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

10.1101/2020.08.26.20182444 ◽

2020 ◽

Cited By ~ 7

Author(s):

Cristina Avendano-Sola ◽

Antonio Ramos-Martinez ◽

Elena Munez-Rubio ◽

Belen Ruiz-Antoran ◽

Rosa Malo de Molina ◽

...

Keyword(s):

Clinical Trial ◽

Mechanical Ventilation ◽

Randomized Clinical Trial ◽

Strong Dependence ◽

Standard Of Care ◽

Ordinal Scale ◽

Control Group ◽

Standard Of Care Treatment ◽

And Control ◽

To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

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A 3-year randomized clinical trial evaluating two different bonded posterior restorations: Amalgam versus resin composite

European Journal of Dentistry ◽

10.4103/1305-7456.175692 ◽

2016 ◽

Vol 10 (01) ◽

pp. 016-022 ◽

Cited By ~ 3

Author(s):

Hande Kemaloglu ◽

Tijen Pamir ◽

Huseyin Tezel

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Public Health Service ◽

Resin Composite ◽

Resin Composites ◽

Composite Restorations ◽

Vas Scores ◽

To Receive ◽

Posterior Restorations ◽

Postoperative Sensitivity

ABSTRACT Objective: To compare the performance and postoperative sensitivity of a posterior resin composite with that of bonded amalgam in 40 (n = 20) large sized cavities and to evaluate whether resin composite could be an alternative for bonded amalgam. Materials and Methods: This was a randomized clinical trial. Twenty patients in need of at least two posterior restorations were recruited. Authors randomly assigned one half of the restorations to receive bonded amalgam and the other half to composite restorations. Forty bonded amalgams (n = 20) and composites (n = 20) were evaluated for their performance on modified-US Public Health Service criteria and postoperative sensitivity using visual analogue scale (VAS) for 36-months. Results: Success rate of this study was 100%. First clinical alterations were rated as Bravo after 1 year in marginal discoloration, marginal adaptation, anatomical form, and surface roughness for both amalgam and composite. At the 3rd year, overall “Bravo” rated restorations were 12 for bonded amalgam and 13 for resin composites. There were no significant differences among the VAS scores of composites and bonded amalgams for all periods (P > 0.05) except for the comparisons at the 3rd year evaluation (P < 0.05). Conclusions: Within the limitation of this study, both resin composite and bonded amalgam were clinically acceptable. Postoperative sensitivity results tend to decrease more in composite restorations rather than amalgams. Therefore, it was concluded that posterior resin composite can be used even in large sized cavities.

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EXCESS MORTALITY FROM COVID-19. WEEKLY EXCESS DEATH RATES BY AGE AND SEX FOR SWEDEN AND ITS MOST AFFECTED REGION

European Journal of Public Health ◽

10.1093/eurpub/ckaa218 ◽

2020 ◽

Author(s):

Karin Modig ◽

Anders Ahlbom ◽

Marcus Ebeling

Keyword(s):

Causes Of Death ◽

Excess Mortality ◽

National Level ◽

Mortality Rates ◽

Regional Level ◽

Death Rates ◽

Excess Death ◽

All Cause Mortality ◽

Specific Mortality ◽

Age And Sex

Abstract Background Sweden has one of the highest numbers of COVID-19 deaths per inhabitant globally. However, absolute death counts can be misleading. Estimating age- and sex-specific mortality rates is necessary in order to account for the underlying population structure. Furthermore, given the difficulty of assigning causes of death, excess all-cause mortality should be estimated to assess the overall burden of the pandemic. Methods By estimating weekly age- and sex-specific death rates during 2020 and during the preceding five years, our aim is to get more accurate estimates of the excess mortality attributed to COVID-19 in Sweden, and in the most affected region Stockholm. Results Eight weeks after Sweden’s first confirmed case, the death rates at all ages above 60 were higher than for previous years. Persons above age 80 were disproportionally more affected, and men suffered greater excess mortality than women in ages up to 75 years. At older ages, the excess mortality was similar for men and women, with up to 1.5 times higher death rates for Sweden and up to 3 times higher for Stockholm. Life expectancy at age 50 declined by less than 1 year for Sweden and 1.5 years for Stockholm compared to 2019. Conclusions The excess mortality has been high in older ages during the pandemic, but it remains to be answered if this is because of age itself being a prognostic factor or a proxy for comorbidity. Only monitoring deaths at a national level may hide the effect of the pandemic on the regional level.

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