The Coast-trial in Africa, led by Professor Sarah Kiguli in Uganda, was approved in 2016 by the Uganda National Health Research Organization and Uganda National Council for Science and Technology. Part of a broader study financed by the UK-based Joint Global Health Trials, they are investigating the best oxygen delivery strategies to reduce mortality and morbidity in African children with respiratory distress complicated by hypoxia in hospital. Participants’ ages range between 28 days and 12 years. Local civil organizations are now organizing to address study practices in court.
The Center for Health, Human Rights and Development, Community Health and Information Network, and Uganda Alliance of Patients Organization filed a lawsuit that alleging that the clinical trials infringe on the children’s fundamental constitutional rights in that country reports the Monitor.
The Study and Allegations
In this study, according to court documents, children are randomly assigned different study arms that include high flow oxygen and another that contains low flow oxygen, and that petitioner claim that this process is endangering the children’s lives. The petitioners reported that they had raised concerns, especially concerning the low flow oxygen and the permissive hypoxia arm, where the study participants receive no oxygen at all, but no action was reportedly taken.
Moreover, they claim that Professor Sarah Kiguli commenced the clinical trial without obtaining a certificate from the National Drug Authority (NDA) in Uganda—regulatory requirements as oxygen are listed as a pharmaceutical and the investigator did not follow the legal procedures delineated in that country, or so it is claimed.
Denial of Care
Ethical questions have been raised regarding this trial. While children were hospitalized for respiratory issues, other life-threatening conditions were present, according to the petitioners, that were not addressed according to the petitioner’s claim, as reported in the Monitor. The investigators discussed only the respiratory issues included in the protocol—but a fundamental tenet of the standard of care, the petitioner, undoubtedly claims that very ill children get treated adequately (standard of care) should they be committed to a particular clinical trial. The petitioners claim some of the children’s lives were put in danger. TrialSite News cannot validate or verify any of these claims.
The study titled “A randomized controlled trial of high flow oxygen versus control in African children with severe pneumonia” aimed to identify which children would benefit from receiving oxygen and what would be the best delivery method.
The study investigators sought to understand whether or not giving oxygen improves patient outcomes. When children have hypoxia, it is not clear what the best level of oxygen should be provided and what contributes to better results. So in the study, investigators randomly allocate those children with less severe hypoxia to either an oxygen arm of the research or no oxygen. While the children with more severe hypoxia all receive oxygen as the sponsor “is more confident as to the benefits with this group.” Those children receiving oxygen than are randomly allocated between “higher flow oxygen” and “lower flow oxygen” groups. Lower flow represents routine care. The high flow option offers extra pressure in the airways to prevent them from collapsing after each exhales—this helps reduce the work involved in breathing– a vital function when lung infections may lead to respiratory exhaustion and ultimately respiratory failure in critically ill children with limited access to proper life support, such as mechanical ventilation. It should be noted these challenging conditions represent a majority of hospitals in African.
Reported benefits included
Closer observation during the first 48 hours of admission, which, as a result, allows doctors and nurses to make necessary changes to the child’s treatment during in-hospital admission. The study offers all non-trial medications required by the hospital to treat the patient are made available (if not open, patents have to resort to finding these on their own). The study covers blood test costs. Moreover, the study covers transport costs as well as snacks.
The study sponsors claimed that high flow oxygen is the accepted strategy in the management of children with respiratory failure in “a multitude” of countries with few reports as to it not being acceptable. Hence based on this statement, they declare this strategy poses an “extremely low” risk to the children.
The petitioners seek immediate order against the Uganda Medical and Dental Practitioners Council to investigate and file a report to the court and parties within a year of judgment on full effects of the protocol of this study—e.g., administering lower levels of oxygen to different children as we as a recommendation for redress.
Research Sites Involved
·Coast Provincial General Hospital, Mombasa, Kenya
·KEMRI Wellcome Trust Programme, Kenya
·Mulago Hospital, Uganda
·Mbale Regional Referral Hospital, Uganda
·Soroti Regional Referral Hospital, Uganda
Lead Research/Investigator in Uganda
Call to Action: An essential claim here is that children were admitted to the study with life-threatening conditions associated with some ethical duties that were not addressed and hence, raised potential legal issues. TrialSite News cannot validate or verify these claims only that there is a legal action in Uganda. The facts could be different than represented, for example. But our mission is to bring transparency and access to critically crucial clinical research—this means reviewing the good and the not so good because with clarity, all things being equal, quality, and care improves. Undoubtedly with the existing legal actions, there are considerable concerns on the ground there. We will monitor this legal action and its accuracy as to the actual workings of the Coast-trial.