MalariaMALHELMINNCT05354258

Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children

A study testing Albendazole, Praziquantel and Amodiaquine in people with Malaria and Soil Transmitted Helminths, run by London School of Hygiene and Tropical Medicine at 1 site in Senegal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 1 year to 14 yearsHealthy volunteers can take part
Conditions the study is for: Malaria, Soil Transmitted Helminths, Schistosomiasis
What is being tested?: Albendazole, Praziquantel and Amodiaquine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 600 participants
Where: 1 siteSenegal
Study dates: 16 Jun 2022to Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male and female children aged 1-14 years;
Provision of a written informed consent by the parent/caregiver and a positive assent by children aged ≥ 12 years (in line with legal regulations in Senegal);
Willingness to provide finger-prick blood samples, urine, and stool samples;
Residence in the study area for at least six months

Who cannot join

Acutely ill child at the time of the drug administration;
Child whose parents/caregivers decline to provide consent;
A known HIV positive child receiving cotrimoxazole prophylaxis;
A child who has received a dose of any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel during the previous six months;
A child with a known allergy to any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel.

Trial locations and contacts

1 site in 1 country.

Senegal1 site

Saraya Health Centre
Saraya, Kedougou, 00221

Other trials in Senegal

About this study

Official title: Feasibility and Effectiveness of Delivering Mass Drug Administration for Helminths Through the Seasonal Malaria Chemoprevention (SMC) Platform in a West African Paediatric Population

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

Conditions: Malaria, Soil Transmitted Helminths, Schistosomiasis, Integrated Control, Seasonal Malaria Chemoprevention, Mass Drug Administration With Anthelminthic Drugs
Being tested: Albendazole, Praziquantel, Amodiaquine, Sulfadoxine pyrimethamine
Medical subject headings: Malaria, Schistosomiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlbendazoleDrug
Anthelminthic drugs for the treatment of soil-transmitted helminths
PraziquantelDrug
Anthelminthic drugs for the treatment of schistosomiasis
AmodiaquineDrug
SMC partner drug
Sulfadoxine pyrimethamineDrug
SMC partner drug

Study groups in NCT05354258
Study group	Role	What they receive
Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3	Placebo comparator	Not described Receives: Drug: Amodiaquine; Drug: Sulfadoxine pyrimethamine
Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3	Experimental	Not described Receives: Drug: Praziquantel; Drug: Amodiaquine; Drug: Sulfadoxine pyrimethamine
Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3	Experimental	Not described Receives: Drug: Albendazole; Drug: Praziquantel; Drug: Amodiaquine; Drug: Sulfadoxine pyrimethamine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: For six consecutive days after start of the drug administration

Secondary outcomes (3)

Prevalence of helminth co-infection
Faecal egg counts for soil transmitted helminths
Measured: 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
Measured: 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
Measured: On the day of randomisation (pre-intervention) and up to 4 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 2022Sep 2023

First posted29 Apr 2022
Study start16 Jun 2022
Primary completion30 Nov 2022 (estimated)
Study completionSep 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05354258
Sponsor's protocol ID: 26770
Acronym: MALHELMIN
Status last verified: Apr 2022
First submitted: 12 Apr 2022
Last updated: 14 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Publications

Afolabi MO, Sow D, Agbla SC, Fall EHB, Sall FB, Seck A, Manga IA, Mbaye IM, Loum MA, Camara B, Niang D, Gueye B, Sene D, Kane NM, Diop B, Diouf A, Gaye NA, Diouf MP, Lo AC, Greenwood B, Ndiaye JLA. Feasibility and safety of integrating mass drug administration for helminth control with seasonal malaria chemoprevention among Senegalese children: a randomized controlled, observer-blind trial. Malar J. 2023 Nov 13;22(1):348. doi: 10.1186/s12936-023-04784-z.
PubMed 37957702
Afolabi MO, Diaw A, Fall EHB, Sall FB, Diedhiou A, Seck A, Camara B, Niang D, Manga IA, Mbaye I, Sougou NM, Sow D, Greenwood B, Ndiaye JLA. Provider and User Acceptability of Integrated Treatment for the Control of Malaria and Helminths in Saraya, South-Eastern Senegal. Am J Trop Med Hyg. 2023 Sep 18;109(5):1047-1056. doi: 10.4269/ajtmh.23-0113. Print 2023 Nov 1.
PubMed 37722662
Afolabi MO, Sow D, Ndiaye JLA, Greenwood B. Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial. Trials. 2022 Aug 3;23(1):627. doi: 10.1186/s13063-022-06579-0.
PubMed 35922819

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Effectiveness of Delivering Mass Drug Administration for Helminths Through the Seasonal Malaria Chemoprevention (SMC) Platform in a West African Paediatric Population
ClinicalTrials.gov ID: NCT05354258
Acronym / sponsor ID: MALHELMIN / 26770
Conditions: Malaria, Soil Transmitted Helminths, Schistosomiasis, Integrated Control, Seasonal Malaria Chemoprevention, Mass Drug Administration With Anthelminthic Drugs
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 600 participants (estimated)
Lead sponsor: London School of Hygiene and Tropical MedicineUniversity, hospital or other
Collaborators: Université de Thies, UFR Santé, Senegal
Study start: 16 Jun 2022 (actual)
Primary completion: 30 Nov 2022 (estimated)
Study completion: Sep 2023 (estimated)
First posted: 29 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3	Placebo comparator	Drug: Amodiaquine, Drug: Sulfadoxine pyrimethamine
Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3	Experimental	Drug: Praziquantel, Drug: Amodiaquine, Drug: Sulfadoxine pyrimethamine
Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3	Experimental	Drug: Albendazole, Drug: Praziquantel, Drug: Amodiaquine, Drug: Sulfadoxine pyrimethamine

Who may qualify

Ages: 1 year to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male and female children aged 1-14 years;
Provision of a written informed consent by the parent/caregiver and a positive assent by children aged ≥ 12 years (in line with legal regulations in Senegal);
Willingness to provide finger-prick blood samples, urine, and stool samples;
Residence in the study area for at least six months

Key exclusion criteria (5 listed)

Acutely ill child at the time of the drug administration;
Child whose parents/caregivers decline to provide consent;
A known HIV positive child receiving cotrimoxazole prophylaxis;
A child who has received a dose of any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel during the previous six months;
A child with a known allergy to any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlbendazoleAnthelminthic drugs for the treatment of soil-transmitted helminths	Drug	Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3
PraziquantelAnthelminthic drugs for the treatment of schistosomiasis	Drug	Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3, Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3
AmodiaquineSMC partner drug	Drug	Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3, Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3, Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3
Sulfadoxine pyrimethamineSMC partner drug	Drug	Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3, Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3, Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: For six consecutive days after start of the drug administration
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.

3 secondary outcomes

Prevalence of helminth co-infection
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Prevalence of Schistosoma co-infection
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Prevalence of intensity of helminth infection
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
Derived from this study: PubMed 37957702Afolabi MO, Sow D, Agbla SC, Fall EHB, Sall FB, Seck A, Manga IA, Mbaye IM, Loum MA, Camara B, Niang D, Gueye B, Sene D, Kane NM, Diop B, Diouf A, Gaye NA, Diouf MP, Lo AC, Greenwood B, Ndiaye JLA. Feasibility and safety of integrating mass drug administration for helminth control with seasonal malaria chemoprevention among Senegalese children: a randomized controlled, observer-blind trial. Malar J. 2023 Nov 13;22(1):348. doi: 10.1186/s12936-023-04784-z.
Derived from this study: PubMed 37722662Afolabi MO, Diaw A, Fall EHB, Sall FB, Diedhiou A, Seck A, Camara B, Niang D, Manga IA, Mbaye I, Sougou NM, Sow D, Greenwood B, Ndiaye JLA. Provider and User Acceptability of Integrated Treatment for the Control of Malaria and Helminths in Saraya, South-Eastern Senegal. Am J Trop Med Hyg. 2023 Sep 18;109(5):1047-1056. doi: 10.4269/ajtmh.23-0113. Print 2023 Nov 1.
Derived from this study: PubMed 35922819Afolabi MO, Sow D, Ndiaye JLA, Greenwood B. Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial. Trials. 2022 Aug 3;23(1):627. doi: 10.1186/s13063-022-06579-0.
Individual participant dataSharing planned: 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

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Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Greenwood, MD, FMedSci study director

London School of Hygiene and Tropical Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Albendazole, Praziquantel and Amodiaquine in people with Malaria and Soil Transmitted Helminths, run by London School of Hygiene and Tropical Medicine at 1 site in Senegal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: For six consecutive days after start of the drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05354258, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.