Overview
• A January 2002 article in The Pediatric Infections Disease Journal discusses the results of a global clinical trial conducted in children with bacterial meningitis comparing intravenous Trovan and Ceftriaxone.
• The research shows that there was no significant difference in outcomes when patients were treated with either Trovan or Ceftriaxone.
• The article concludes that Trovan is an effective antibiotic for the treatment of pediatric bacterial meningitis.
Clinical Trial Background
• The purpose of the trial was to compare the safety and efficacy of Trovan with that of Ceftriaxone.
• The clinical trial was conducted from April 28, 1998 to July 12, 1999 in multiple sites in 11 countries in North, Central and South America, Egypt, South Africa and Hungary.
• The clinical trial received approval from the review boards of each participating institution.
• Parents or legal guardians of the children, aged three months to 12 years, provided written informed consent to participate in the clinical trial.
• All of the children who participated in the clinical trial had signs and symptoms suggesting bacterial meningitis and CSF analysis compatible with bacterial cause.
Clinical Trial Results
• The results from the trial concluded that there were no significant differences between Trovan and Ceftriaxone. Five to seven weeks after treatment, there was a clinical success rate of 78 percent for Trovan and 81 percent for Ceftriaxone; as well as a death rate of two percent for Trovan and three percent for Ceftriaxone.
• The results suggest that Trovan is therapeutically equivalent to Ceftriaxone for the management of bacterial meningitis in infants and children.
• Rates of bacterial eradication, cure, severe sequelae and death were similar for both treatment groups at the end of treatment and at follow-up assessments.
• The study was terminated earlier than planned due to concerns regarding liver toxicity associated with the use of Trovan in adults with severe infections. However, none of the evaluable children developed any significant liver abnormalities.
Conclusion
• The authors conclude that Trovan is an effective antibiotic for treatment of pediatric bacterial meningitis. The results lead the authors to support further evaluation of such therapy for children with meningitis or other serious bacterial infections.
* Source: Saez-Llorens, Xavier, et al. 2002. Quinolone treatment for pediatric bacterial meningitis: a comparative study of trovafloxacin and ceftriaxone with or without vancomycin. The Pediatric Infections Disease Journal 21(1): 14-22.
Monday, February 22, 2010
Tuesday, February 2, 2010
Clinical Trials in Africa
“There is much work to do, but the importance of treatment and public health benefits brought by clinical trials to Africa cannot be over-estimated.”
Culled from “Afroguide: Putting Africa on the Clinical Trials Map” by Samantha Etkin
See:
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Other+Regions/AfroGuide-Putting-Africa-on-the-Clinical-Trials-Ma/ArticleStandard/Article/detail/522045
Culled from “Afroguide: Putting Africa on the Clinical Trials Map” by Samantha Etkin
See:
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Other+Regions/AfroGuide-Putting-Africa-on-the-Clinical-Trials-Ma/ArticleStandard/Article/detail/522045
The Spread of Polio in Nigeria
While the rest of the world has banished polio beyond their borders, Nigeria is still mired in a mixture of politics, superstition and outright wickedness which makes the elite spread false rumours about the immunization exercise while immunizing their own children. How come only the children of the poor are afflicted by polio when immunization is free? The Nigerian elite play politics with everything, including human lives. Perhaps their calculation is that the best way to keep the people down is to keep them crippled – literally – by polio. The World Health Organisation’s report below is quite instructive …
http://www.who.int/csr/don/2009_07_17/en/index.html
Polio in Nigeria
In 2009, the northern states of Nigeria have experienced a large polio outbreak due to wild poliovirus type 3 (WPV3) with 258 cases, compared to 32 cases for the same period in 2008. WPV3 from northern Nigeria has this year spread internationally to Niger. Since February 2009, there has also been an increasing number of polio cases due to a type 2 circulating vaccine-derived poliovirus (cVDPV2) in northern Nigeria (103 cases to date in 2009 compared to 31 cases for the same period in 2008). Both serotypes are at continued, and in the case of the cVDPV2 increasing, risk of international spread. While the number of cVDPV2 cases is lower than WPV3 cases, circulation of this serotype is of particular international concern as the last case of polio due to a circulating wild poliovirus type 2 (WPV2) was in 1999.
In response to these risks, Nigeria has conducted nationwide polio supplementary immunization activities (SIAs) with monovalent OPV type 3 (mOPV3) in late January 2009 and with trivalent OPV from 30 May to 2 June. Additional SIAs are planned for later in the year, including an SIA with trivalent OPV for August.
To minimize the risk and consequences of international spread of these polioviruses, countries across west and central Africa, particularly those bordering the affected states of northern Nigeria, should enhance surveillance for acute flaccid paralysis (AFP), identify subnational population immunity gaps, and strengthen routine immunization with trivalent OPV. Countries affected by poliovirus importations should continue to supplement routine immunization with large-scale outbreak response activities with the relevant OPV, as per the WHA Resolution WHA59.1.
http://www.who.int/csr/don/2009_07_17/en/index.html
Polio in Nigeria
In 2009, the northern states of Nigeria have experienced a large polio outbreak due to wild poliovirus type 3 (WPV3) with 258 cases, compared to 32 cases for the same period in 2008. WPV3 from northern Nigeria has this year spread internationally to Niger. Since February 2009, there has also been an increasing number of polio cases due to a type 2 circulating vaccine-derived poliovirus (cVDPV2) in northern Nigeria (103 cases to date in 2009 compared to 31 cases for the same period in 2008). Both serotypes are at continued, and in the case of the cVDPV2 increasing, risk of international spread. While the number of cVDPV2 cases is lower than WPV3 cases, circulation of this serotype is of particular international concern as the last case of polio due to a circulating wild poliovirus type 2 (WPV2) was in 1999.
In response to these risks, Nigeria has conducted nationwide polio supplementary immunization activities (SIAs) with monovalent OPV type 3 (mOPV3) in late January 2009 and with trivalent OPV from 30 May to 2 June. Additional SIAs are planned for later in the year, including an SIA with trivalent OPV for August.
To minimize the risk and consequences of international spread of these polioviruses, countries across west and central Africa, particularly those bordering the affected states of northern Nigeria, should enhance surveillance for acute flaccid paralysis (AFP), identify subnational population immunity gaps, and strengthen routine immunization with trivalent OPV. Countries affected by poliovirus importations should continue to supplement routine immunization with large-scale outbreak response activities with the relevant OPV, as per the WHA Resolution WHA59.1.
Nigeria, Niger hardest hit by 2009 meningitis epidemic – UN health agency
Crowded markets and living quarters in Nigeria's most populated state, Kano, increase the risk of a meningitis outbreak
27 March 2009 – A vast majority of the nearly 25,000 suspected meningitis cases and more than 15,000 deaths worldwide in the first three months of 2009 have occurred in the so-called “African meningitis belt,” hitting Nigeria and Niger the hardest, the United Nations health agency has reported.
The bulk of the cases in the meningitis belt, stretching from Senegal to Somalia, has been in northern Nigeria, reporting 17,462 suspected cases and 960 deaths, and Niger, with 4,513 suspected cases and 169 deaths, according to the World Health Organization (WHO).
Vaccination campaigns are underway in the two countries, with the support of WHO, the UN Children’s Fund (UNICEF) and the non-governmental organization Médecins Sans Frontières (MSF).
WHO, which is supporting the Nigerian Health Ministry’s efforts to boost disease surveillance, has had technical experts on the ground since last month.
Along with its partners, WHO has released 2.3 million doses of vaccines to Nigeria and 1.9 million to Niger. Nearly 13 million doses were stockpiled for 2009, but more are needed for this meningitis season which will run from January through June.
Source: http://www.un.org/apps/news/story.asp?NewsID=30327&Cr=health&Cr1=
27 March 2009 – A vast majority of the nearly 25,000 suspected meningitis cases and more than 15,000 deaths worldwide in the first three months of 2009 have occurred in the so-called “African meningitis belt,” hitting Nigeria and Niger the hardest, the United Nations health agency has reported.
The bulk of the cases in the meningitis belt, stretching from Senegal to Somalia, has been in northern Nigeria, reporting 17,462 suspected cases and 960 deaths, and Niger, with 4,513 suspected cases and 169 deaths, according to the World Health Organization (WHO).
Vaccination campaigns are underway in the two countries, with the support of WHO, the UN Children’s Fund (UNICEF) and the non-governmental organization Médecins Sans Frontières (MSF).
WHO, which is supporting the Nigerian Health Ministry’s efforts to boost disease surveillance, has had technical experts on the ground since last month.
Along with its partners, WHO has released 2.3 million doses of vaccines to Nigeria and 1.9 million to Niger. Nearly 13 million doses were stockpiled for 2009, but more are needed for this meningitis season which will run from January through June.
Source: http://www.un.org/apps/news/story.asp?NewsID=30327&Cr=health&Cr1=
Monday, February 1, 2010
Over 600 Claimants for Pfizer Settlement Funds?
Although 200 patients participated in the Trovan trials in 1996 when 100 of them were placed on the gold standard drug and the other 100 were given Trovan, more than 600 people have already filled and submitted their application forms claiming to be ‘victims’ of the Trovan trials.
In a typically Nigerian scenario, queuing up in front of the headquarters of the Trust Fund set up to administer the funds has become a full time occupation for the claimants. It had been speculated for a long time that all sorts of claimants would be coming out of the woodwork as soon as there was indication that the Trovan cases would be settled out of court. Unfortunately, those who raised alarm at that time were demonized and called unprintable names by the so-called Trovan Victims’ Forum. Now that the worst fears of those who care about the image of Nigeria have materialized, the Board of Trustees is saddled with the unenviable task of sifting out the liars and crooks among the claimants. It is now clear to the whole nation why some of the more noisy self-appointed ‘stakeholders’ were campaigning against the use of DNA tests to determine the veracity of claims. At a stage, one of the grandmasters actually said the use of DNA was unislamic. He kept repeating that line until the Emir of Kano, a wise man who saw through the schemes and posturing, declared that the use of DNA and other parameters would help ensure that only the right beneficiaries accessed the funds.
Many analysts and close watchers of goings on in Kano since the announcement of the settlement are now wondering what would become of the new industry of ‘victimhood’ which developed around the settlement issue. There were allegations of people going round families and hiring their disabled members to come and pose as Pfizer victims. It will be interesting to see how many of those in the pictures distributed all over the media in the heat of the litigation eventually turn out to be genuine claimants. But for now it is clear that those who were hoping that money would just be handed over to anyone with any form of disability even where that individual was born disabled are living in a fool’s paradise.
One thing that none of the nay Sayers has been able to challenge is the integrity of the Board. It is generally conceded that the Board is made up of men and women of high integrity. It would be difficult for the crooks to blackmail the Board, but they are already giving blackmail a try, if feelers coming out of the grapevine are anything to go by. What the unscrupulous crowd thought was that once they demonize the Board and further cast aspersions on the integrity of Pfizer, fat cheques would be dropped on their laps like hot potato. They didn’t reckon that for once some people are going to insist on absolute transparency. Now their camp is in disarray. But nobody is fooled by the lull in their open campaign because reports indicate that they have gone underground to avoid a direct collision with the traditional authorities.
The important thing is that finally transparency is going to be the guiding principle of the entire exercise and all those who participated in the Trovan trials of 1996 will be compensated under the principle of more money for more verifiable health problem, that is a patient without any form of impairment will receive far less than one with verifiable disability. That sounds fair.
What is frightening is that some people could have it in their mind to take advantage of a tragic situation which resulted from a tragic epidemic to plot a diabolical scheme to make false claims and deprive the real patients their just due.
It is hoped that the Board will stay the course and not allow itself to be distracted by the plots and sub-plots of 419ers posing as ‘victims’.
Judging from the caliber of the men and women on that Board, one can rest assured that they will rise up to the challenge.
In a typically Nigerian scenario, queuing up in front of the headquarters of the Trust Fund set up to administer the funds has become a full time occupation for the claimants. It had been speculated for a long time that all sorts of claimants would be coming out of the woodwork as soon as there was indication that the Trovan cases would be settled out of court. Unfortunately, those who raised alarm at that time were demonized and called unprintable names by the so-called Trovan Victims’ Forum. Now that the worst fears of those who care about the image of Nigeria have materialized, the Board of Trustees is saddled with the unenviable task of sifting out the liars and crooks among the claimants. It is now clear to the whole nation why some of the more noisy self-appointed ‘stakeholders’ were campaigning against the use of DNA tests to determine the veracity of claims. At a stage, one of the grandmasters actually said the use of DNA was unislamic. He kept repeating that line until the Emir of Kano, a wise man who saw through the schemes and posturing, declared that the use of DNA and other parameters would help ensure that only the right beneficiaries accessed the funds.
Many analysts and close watchers of goings on in Kano since the announcement of the settlement are now wondering what would become of the new industry of ‘victimhood’ which developed around the settlement issue. There were allegations of people going round families and hiring their disabled members to come and pose as Pfizer victims. It will be interesting to see how many of those in the pictures distributed all over the media in the heat of the litigation eventually turn out to be genuine claimants. But for now it is clear that those who were hoping that money would just be handed over to anyone with any form of disability even where that individual was born disabled are living in a fool’s paradise.
One thing that none of the nay Sayers has been able to challenge is the integrity of the Board. It is generally conceded that the Board is made up of men and women of high integrity. It would be difficult for the crooks to blackmail the Board, but they are already giving blackmail a try, if feelers coming out of the grapevine are anything to go by. What the unscrupulous crowd thought was that once they demonize the Board and further cast aspersions on the integrity of Pfizer, fat cheques would be dropped on their laps like hot potato. They didn’t reckon that for once some people are going to insist on absolute transparency. Now their camp is in disarray. But nobody is fooled by the lull in their open campaign because reports indicate that they have gone underground to avoid a direct collision with the traditional authorities.
The important thing is that finally transparency is going to be the guiding principle of the entire exercise and all those who participated in the Trovan trials of 1996 will be compensated under the principle of more money for more verifiable health problem, that is a patient without any form of impairment will receive far less than one with verifiable disability. That sounds fair.
What is frightening is that some people could have it in their mind to take advantage of a tragic situation which resulted from a tragic epidemic to plot a diabolical scheme to make false claims and deprive the real patients their just due.
It is hoped that the Board will stay the course and not allow itself to be distracted by the plots and sub-plots of 419ers posing as ‘victims’.
Judging from the caliber of the men and women on that Board, one can rest assured that they will rise up to the challenge.
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