An interventional study of Albendazole and Praziquantel in Malaria, Soil Transmitted Helminths and Schistosomiasis, sponsored by London School of Hygiene and Tropical Medicine. Status unknown at 1 site in Senegal. Open to participants aged 1 Year to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Prevention
Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 600 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Amodiaquine · Drug: Sulfadoxine pyrimethamine
Drug: Praziquantel · Drug: Amodiaquine · Drug: Sulfadoxine pyrimethamine
Drug: Albendazole · Drug: Praziquantel · Drug: Amodiaquine · Drug: Sulfadoxine pyrimethamine
Anthelminthic drugs for the treatment of soil-transmitted helminths
Anthelminthic drugs for the treatment of schistosomiasis
SMC partner drug
SMC partner drug
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events will be measured by collecting solicited and unsolicited adverse events and adverse drug reactions for causal relationships to the study drugs.
Time frame: For six consecutive days after start of the drug administration
Prevalence of helminth co-infection
Faecal egg counts for soil transmitted helminths
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Prevalence of Schistosoma co-infection
Urine egg counts for Schistosoma haematobium
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Prevalence of intensity of helminth infection
Arithmetic mean intensity of helminth infection
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Prevalence of anaemia
Haemoglobin concentration of all study children will be checked using HemoCue®
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Plan to share: Yes — We will share the summary results of this trial or a link to the summary results within the trial registration record within 12 months of the study completion date
Supporting information: Study protocol
Time frame: Within 12 months of the study completion date
Access criteria: Open access requests will be entertained, the decision will be made by the Principal Investigator, quality of the request will be reviewed before granting it
Started Jun 2022 (actual). Primary completion is estimated for Nov 2022, 5 months after the start.
Of 95 non-industry interventional studies with no phase under Malaria, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 5 months is below that.
Counting every sponsor, half of 101 studies reached it within 23 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Albendazole · Praziquantel
London School of Hygiene and Tropical Medicine →